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Clinical trial

MRI based evaluation of carcinoma gallbladder using apparent diffusion coefficient (ADC) and diffusion weighted imaging (DWI)

[version 1; peer review: 1 approved]
Sakshi Dudhe
https://orcid.org/0009-0008-9176-4044
1, Gaurav Mishra1, Pratapsingh Parihar1, Dhananjay Shinde
https://orcid.org/0009-0008-5426-9650
1, Anjali Kumari
https://orcid.org/0009-0005-6942-2900
1
Sakshi Dudhe
https://orcid.org/0009-0008-9176-4044
1, Gaurav Mishra1, [...] Pratapsingh Parihar1, Dhananjay Shinde
https://orcid.org/0009-0008-5426-9650
1, Anjali Kumari
https://orcid.org/0009-0005-6942-2900
1
PUBLISHED 29 Apr 2024
Author details Author details
OPEN PEER REVIEW
REVIEWER STATUS

This article is included in the Datta Meghe Institute of Higher Education and Research collection.

Abstract

Background

Carcinoma of the gallbladder is a malignant neoplasm, which is associated with a poor prognosis due to its often-asymptomatic nature and late-stage diagnosis. Non-invasive imaging techniques play a key role in the early detection and characterization of gallbladder carcinoma. This thesis presents a comprehensive analysis of the utility of Diffusion-Weighted Imaging (DWI) and Apparent Diffusion Coefficient (ADC) mapping in the magnetic resonance imaging (MRI) evaluation of carcinoma of the gallbladder. The primary objective of this research was to investigate the exact diagnostic accuracy and potential clinical applications of DWI and ADC in assessing carcinoma of the gallbladder and related tumour aggressiveness. A systematic review of existing literature was conducted to establish a foundation for this study with efforts to acquire relevant imaging data. The results of this study demonstrate the efficacy of DWI and ADC in the detection of carcinoma of the gallbladder when compared to conventional MRI sequences. These advanced imaging techniques hold promise in increasing the accuracy of diagnosis, ultimately leading to improved patient outcomes and more informed clinical decision making. The potential of Diffusion-Weighted Imaging (DWI) and Apparent Diffusion Coefficient (ADC) mapping in the evaluation of gallbladder cancer using magnetic resonance imaging (MRI) is thoroughly analysed in this thesis.

Methods

A descriptive prospective study will be done at Acharya Vinoba Bhave Rural Hospital, Sawangi, involving 20 patients with clinically suspected carcinoma gallbladder, who are referred to the department of Radiodiagnosis. These patients will be subjected to study-purposive sampling.

Conclusion

After an appropriate statistical analysis, we expect to assess the role of Diffusion-Weighted Imaging (DWI) and Apparent Diffusion Coefficient (ADC) mapping in the magnetic resonance imaging (MRI) evaluation of carcinoma of the gallbladder.

CTRI registration

This trial has been submitted to Clinical Trials Registry-India (CTRI) for Review.

Registration Number: REF/2023/09/072780

Registration date:01/05/2023

URL of trial: https://www.ctri.nic.in/

Keywords

MRI, DWI, ADC, gallbladder carcinoma, b values, gallbladder

Corresponding author: Sakshi Dudhe
Competing interests: No competing interests were disclosed.
Grant information: Intramural grant of Rs 24,000 was funded by Datta Meghe Institute of Higher Education and Research, Sawangi, Wardha.
Copyright:  © 2024 Dudhe S et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
How to cite: Dudhe S, Mishra G, Parihar P et al. MRI based evaluation of carcinoma gallbladder using apparent diffusion coefficient (ADC) and diffusion weighted imaging (DWI) [version 1; peer review: 1 approved]. F1000Research 2024, 13:414 (https://doi.org/10.12688/f1000research.143953.1) First published: 29 Apr 2024, 13:414 (https://doi.org/10.12688/f1000research.143953.1) Latest published: 29 Apr 2024, 13:414 (https://doi.org/10.12688/f1000research.143953.1)

Introduction

Background and rationale

Carcinoma of the gallbladder, although relatively uncommon, is a highly belligerent type of malignancy associated with a grim prognosis.1 It is often diagnosed at advanced stages, leading to limited treatment options leading to poor survival rates.2 This unfortunate reality underscores the critical need for improved methods of early detection, accurate staging, and precise characterization of gallbladder carcinoma. Non-invasive imaging techniques have emerged as indispensable tools in addressing these challenges, with Magnetic Resonance Imaging (MRI) at the forefront.3 This thesis aims to establish and validate a proper standard methodology for MRI based evaluation of gallbladder cancer utilizing Diffusion-Weighted Imaging (DWI) and the Apparent Diffusion Coefficient (ADC) as its key components.

The clinical significance of gallbladder carcinoma: In the field of oncology, Gallbladder carcinoma is a challenge. Often due to delay in diagnosis of this sneaky malignancy, the patient presents when the disease progresses to advanced stage with complications like local invasion and distant metastasis.4 The overall prognosis remains poor, with approximate 5-year survival rate of these patients less than 5% for advanced stage Gallbladder carcinoma.1 In such cases, early detection is paramount to improving patient outcomes.

The limitations of conventional imaging: Conventional imaging modalities like Computed Tomography (CT) and Ultrasound have been the torch bearers for diagnosis of gallbladder carcinoma. Even though used for preliminary stage scanning, they have their limitations in proper evaluation. Differentiating between gallbladder lesions can be challenging, and accurately assessing the extent of tumor invasion is often imprecise. Such diagnostic insufficiency can lead to delayed or inadequate treatment. The diagnostic potential of DWI and ADC for identifying gallbladder diseases can be of immense help.5

The potential of mri in gallbladder carcinoma: Magnetic Resonance Imaging (MRI) is becoming more and more recognized as an essential approach in differentiating pathologies related to gall bladder. MRI has an upper hand not only due to its multiparametric capabilities and superior soft tissue contrast, but also considering the absence of ionizing radiation DWI and ADC are evolving diagnostic tools as compared to conventional biliary imaging techniques.6 MRI allows detailed visualization of gallbladder and its surrounding structures. Moreover, MRI has shown promise in differentiating malignant gallbladder lesions as well.

Facilitation of early detection: The primary reason for the development of a standardized MRI technique using DWI and ADC in the evaluation of carcinoma of gallbladder is for enhancing early detection. Delay in diagnosis is mainly due to the asymptomatic nature of the disease. However, tissue microstructure can be studied using DWI and ADC for the recognizing restricted water diffusion patterns, which are characteristic of malignant lesions.7 Therefore, we present this study protocol for facilitating the early detection of gallbladder carcinoma and impact patient survival rates and overall prognosis.

Improving diagnostic accuracy: DWI and ADC gives a distinct advantage in analyzing gallbladder lesions by measuring water diffusion inside the tissues. Lower ADC values are seen in malignant tumors due to its altered cellular density and altered membrane integrity, in comparison to benign lesions.8 Diagnostic accuracy can be improved due to implementation of a standardized protocol for their use in gallbladder carcinoma evaluation. This can further can lead to reduced misdiagnosis or delay in diagnosis, which will guide the clinicians toward more appropriate treatment strategies.

Unlocking prognostic insights: Numerous studies have shown ADC values and histopathological correlations, indicating that ADC values might be highly predictable in terms of tumor behavior.9 This study seeks to investigate the evolving importance of ADC in gallbladder carcinoma, by adopting a structured strategy of data collection and analysis, potentially guiding treatment decisions and patient management.

Standardization and reproducibility: Finally, for promoting consistency and reproducibility in our clinical practice, establishing a standardized MRI protocol for gallbladder carcinoma evaluation using DWI and ADC becomes essential. Improper imaging protocols can lead to disparities in disease interpretation and its treatment decisions. A standardized strategy ensures that findings are comparable in different clinical settings, facilitating collaboration and research efforts to bring about advancements in understanding of this challenging malignancy.10

As a result, optimizing the clinical management of this aggressive malignancy will need the establishment and validation of a standardized MRI procedure utilizing DWI and ADC for the evaluation of gallbladder carcinoma.4 By addressing the limitations of conventional imaging, enhancing early detection, improving diagnostic accuracy, and potentially unlocking prognostic insights, this protocol has the potential to significantly impact patient outcomes. Furthermore, by promoting standardization and reproducibility, it contributes to the broader effort to advance research and collaboration in the field of gallbladder carcinoma evaluation.

Protocol

Methods

Registration

This trial has been registered with CTRI for Review-Acknowledgement Number: REF/2023/09/072780.

Ethics and consent

The protocol got its approval from the Institutional Ethics Committee of Datta Meghe Institute of Higher Education and Research DMIMS (DU)/IEC/2023/761. All the patients that are referred to the department of radiodiagnosis, AVBRH, Sawangi with clinically suspected carcinoma gallbladder will be subjected to the study – purposive sampling. Written informed consent will be obtained from the patients after describing the complications of the procedure to the patient as approved by ethics committee. A proforma shall be filled.

Aim

To evaluate role of ADC and DWI in analyzing patients with gallbladder carcinoma.

Design

Prospective cross sectional analytical study with purposive sampling.

Participants:

  • • Inclusion criteria: Patients undergoing MRI scan for with clinically suspected carcinoma gallbladder, referred to Department of Radiodiagnosis for investigative purpose.

  • • Patients with biopsy proven gallbladder carcinoma on HPE.

  • • Patients of suspected gallbladder cancer within all age groups irrespective of their sex will be included.

    Exclusion criteria:

  • • Patients with prior surgery for gallbladder carcinoma.

  • • Pregnant patients.

  • • Patients with metallic implants, pacemaker/cochlear implant.

  • • Patients with claustrophobia/another psychiatric abnormality.

  • • Uncooperative patients and those refusing to give informed consent.

Sample size

The study included 20 patients who had been sent to Acharya Vinoba Bhave Rural Hospital in Sawangi (Meghe) with known or suspected gall bladder cancer. Both IPD and OPD patients are included in the sample.

Cochran Formula for Sample size

n=Zα/22⋅P⋅(1−P)E2

Where; Zα/22 is the level of significance at 5% i.e., 95% confidence interval = 1.96

P = Incidence of Gall Bladder Cancer = 1.2% = 0.012

E=Error of Margin=5%=0.05n=1.962×0.012×(1−0.012)0.052

n = 18.21, n = 20 patients are required for the study.

Duration of study: 2 years.

Study reference: NCBI

Sample Size in Statistics (How to Find it): Excel, Cochran’s Formula, General Tips - Statistics How To. Accessed: April 23, 2024. https://www.statisticshowto.com/probability-and-statistics/find-sample-size/.

Procedure for MRI evaluation of gallbladder cancer patients:

  • • In our study, consent of the patient shall be filled by those willing to undergo MRI for evaluation of Gallbladder. A Proforma shall be filled by the patient following which procedure and complications shall be explained.

  • • To evaluate ADC values at respective areas of gallbladder neoplasm for patients with suspected GB carcinoma.

  • • To calculate the ADC values, ROI shall be selected and ADC mapping by the shall be done.

  • • Appropriate statistical tests will be incorporated post data collection and correlation will be done between ADC values.

Objectives:

Primary objective:

  • • To evaluate role of ADC and DWI in analyzing patients with gallbladder carcinoma.

Secondary objective:

  • • To calculate the Apparent Diffusion Coefficient value at areas of gallbladder carcinoma.

  • • To calculate mean Apparent Diffusion Coefficient value.

To correlate ADC values with b values.

Discussion

MRI is considered helpful, noninvasive tool for diagnosing malignancies related Gallbladder, which further helps to carry out surgical treatment of the patient. DWI is helpful in measuring random Brownian motion of moving water molecules. Early diagnosis can improve clinical outcome and cure rates. Application of diffusion-weighted imaging (DWI) is one of the evolving and latest advancement in MRI. ADC values can be evaluated quantitatively for monitoring therapeutic outcomes in patients with Gallbladder cancer. With our study, we plan to use DWI sequence of MR in patients with Gallbladder cancer for calculating ADC values as a part of our research. MRI plays a critical role by helping in better delineation of Gallbladder carcinoma as compared to any other radiological scan. This further helps in proper diagnosis and better patient care.

Sugita et al. (2009): found out that High b-value DWI showed promise in detecting gallbladder carcinoma, suggesting its potential as a valuable diagnostic tool.11

Kim et al. (2013) found out that DWI plays a crucial role in diagnosing gallbladder cancer, offering valuable information for clinical assessment.12

Yoshioka et al. (2013) established specific ADC cut-off values, helping in the differentiation of various gallbladder lesions based on their ADC values.13 Top of Form

Min et al. (2019) found that ADC was considered a potential marker for gallbladder tumor differentiation and long-term clinical outcomes.14

Wu et al. (2020) found out that initial clinical experiences with reduced field-of-view DWI indicated its utility in gallbladder carcinoma evaluation.15

Tan and Lim (2013) has reviewed the role of MRI, including DWI, in gallbladder cancer, emphasizing its importance in clinical practice.16

Ethics and consent

The protocol got its approval from the Institutional Ethics Committee of Datta Meghe Institute of Higher Education and Research (Reg no.-ECR/440/Inst/MH/2013/RR-2019) with approval number DMIMS (DU)/IEC/2023/761 on 21/03/2023. All the patients that are referred to the department of radiodiagnosis, AVBRH, Sawangi with clinically suspected carcinoma gallbladder will be subjected to the study – purposive sampling. Written informed consent will be obtained from the patients after describing the complications of the procedure to the patient. A proforma shall be filled.

Data management NT

This study material will be considered to be confidential and will be safely stored with access only to the principal investigator.

Study status

The data collection has not been started yet.

Data availability

Underlying data

No data are associated with this article.

Extended data

Zenodo: Proforma for the data collections ‘MRI based evaluation of carcinoma gallbladder using apparent diffusion coefficient (ADC) and diffusion weighted imaging (DWI) in rural Indian population’, https://doi.org/10.5281/zenodo.10973483. 17

Data are available under the terms of the Creative Commons Attribution 4.0 International license (CC-BY 4.0).

References

  • 1.  Hundal R, Shaffer EA: Gallbladder cancer: epidemiology and outcome. Clin. Epidemiol. 2014; 99–109.
  • 2.  Duffy A, Capanu M, Abou-Alfa GK, et al.: Gallbladder cancer (GBC): 10-year experience at memorial Sloan-Kettering cancer centre (MSKCC). J. Surg. Oncol. 2008; 98(7): 485–489. PubMed Abstract | Publisher Full Text
  • 3.  Esnaola NF, Meyer JE, Karachristos A, et al.: Evaluation and management of intrahepatic and extrahepatic cholangiocarcinoma. Cancer. 2016; 122(9): 1349–1369. Publisher Full Text
  • 4.  Misra S, Chaturvedi A, Misra NC, et al.: Carcinoma of the gallbladder. Lancet Oncol. 2003; 4(3): 167–176. Publisher Full Text
  • 5.  Goel S, Kumar R, Chattopadhyay TK, et al.: Role of imaging in the diagnosis of gallbladder carcinoma. World J. Radiol. 2014; 6(12): 840–846.
  • 6.  Gourtsoyianni S, Papanikolaou N, Karantanas A: Magnetic resonance imaging of the gallbladder: Value of T2- and diffusion-weighted imaging in diagnosing acute cholecystitis. J. Magn. Reson. Imaging. 2009; 30(1): 166–174.
  • 7.  Le Bihan D, Breton E, Lallemand D, et al.: Separation of diffusion and perfusion in intravoxel incoherent motion MR imaging. Radiology. 1988; 168(2): 497–505. Publisher Full Text
  • 8.  Koh DM, Collins DJ: Diffusion-weighted MRI in the body: applications and challenges in oncology. Am. J. Roentgenol. 2007; 188(6): 1622–1635. PubMed Abstract | Publisher Full Text
  • 9.  Parikh J, Selmi M, Charles-Edwards G, et al.: Changes in primary breast cancer heterogeneity may augment midtreatment MR imaging assessment of response to neoadjuvant chemotherapy. Radiology. 2014; 272(1): 100–112. PubMed Abstract | Publisher Full Text
  • 10.  Tofts PS, Brix G, Buckley DL, et al.: Estimating kinetic parameters from dynamic contrast-enhanced T1-weighted MRI of a diffusable tracer: standardized quantities and symbols. J. Magn. Reson. Imaging. 1999; 10(3): 223–232. PubMed Abstract | Publisher Full Text
  • 11.  Sugita R, Yamazaki T, Furuta A, et al.: High b-value diffusion-weighted MRI for detecting gallbladder carcinoma: preliminary study and results. Eur. Radiol. 2009; 19: 1794–1798. PubMed Abstract | Publisher Full Text
  • 12.  Kim SJ, Lee JM, Kim H, et al.: Role of diffusion-weighted magnetic resonance imaging in the diagnosis of gallbladder cancer. J. Magn. Reson. Imaging. 2013; 38(1): 127–137. PubMed Abstract | Publisher Full Text
  • 13.  Yoshioka M, Watanabe G, Uchinami H, et al.: Diffusion-weighted MRI for differential diagnosis in gallbladder lesions with special reference to ADC cut-off values. Hepato-Gastroenterology. 2013; 60(124): 692–698. PubMed Abstract
  • 14.  Min JH, Kang TW, Cha DI, et al.: Apparent diffusion coefficient as a potential marker for tumour differentiation, staging and long-term clinical outcomes in gallbladder cancer. Eur. Radiol. 2019; 29(1): 411–421. PubMed Abstract | Publisher Full Text
  • 15.  Wu S, Zou X, Wang Q, et al.: Gallbladder carcinoma: an initial clinical experience of reduced field-of-view diffusion-weighted MRI. Cancer Imaging. 2020; 20: 1–8. Publisher Full Text
  • 16.  Tan CH, Lim KS: MRI of gallbladder cancer. Diagn. Interv. Radiol. 2013; 19(4): 312–319. PubMed Abstract | Publisher Full Text
  • 17.  Dudhe S: MRI based evaluation of carcinoma gallbladder using apparent diffusion coefficient (ADC) and diffusion weighted imaging (DWI) in rural Indian population. Published Online First: 15 April 2024. Publisher Full Text

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Dudhe S, Mishra G, Parihar P et al. MRI based evaluation of carcinoma gallbladder using apparent diffusion coefficient (ADC) and diffusion weighted imaging (DWI) [version 1; peer review: 1 approved]. F1000Research 2024, 13:414 (https://doi.org/10.12688/f1000research.143953.1)
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Reviewer Report 10 Dec 2024
Angel Justiz-Vaillant, The University of the West Indies at St Augustine, Saint Augustine, Trinidad and Tobago 
Approved
VIEWS 5
https://doi.org/10.5256/f1000research.157683.r345047
  1. Relevant Topic:
    The study addresses an important diagnostic challenge in gallbladder carcinoma using advanced imaging techniques. The integration of DWI and ADC mapping in MRI is innovative and clinically relevant.
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Justiz-Vaillant A. Reviewer Report For: MRI based evaluation of carcinoma gallbladder using apparent diffusion coefficient (ADC) and diffusion weighted imaging (DWI) [version 1; peer review: 1 approved]. F1000Research 2024, 13:414 (https://doi.org/10.5256/f1000research.157683.r345047)
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  • Author Response 12 Dec 2024
    Sakshi Dudhe, Department of Radiodiagnosis, Datta Meghe Institute of Higher Education and Research, Sawangi, Wardha, 442107, India
    12 Dec 2024
    Author Response
    Thank you so much for completing the review. I hope the rest of the reviews will be completed in time.
    Competing Interests: No competing interests were disclosed.
    Report a concern
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COMMENTS ON THIS REPORT
  • Author Response 12 Dec 2024
    Sakshi Dudhe, Department of Radiodiagnosis, Datta Meghe Institute of Higher Education and Research, Sawangi, Wardha, 442107, India
    12 Dec 2024
    Author Response
    Thank you so much for completing the review. I hope the rest of the reviews will be completed in time.
    Competing Interests: No competing interests were disclosed.
    Report a concern

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  1. Angel Justiz-Vaillant, The University of the West Indies at St Augustine, Saint Augustine, Trinidad and Tobago

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    Alongside their report, reviewers assign a status to the article:
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    Approved with reservations - A number of small changes, sometimes more significant revisions are required to address specific details and improve the papers academic merit.
    Not approved - fundamental flaws in the paper seriously undermine the findings and conclusions
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