A prospective observational role of magnetic resonance imaging and magnetic resonance spectroscopy in evaluation of choline levels in gall bladder carcinoma in tertiary care hospital in central India

Aim

This study aims to investigate the role of MRI and MR spectroscopy in evaluating choline levels in gall bladder carcinoma.

Objectives

Study design

This study will utilize a prospective observational design to evaluate the role of MRI and MR spectroscopy in assessing choline levels in gall bladder carcinoma. Patients meeting the inclusion criteria will undergo MRI scans, and MR spectroscopy will be conducted to analyze choline levels. Data will be collected and analyzed to fulfill the study objectives.

Study population

The study population will include patients with suspected or diagnosed cases of gall bladder carcinoma. Inclusion criteria will involve patients who consent to participate, do not have contraindications for MRI or MR spectroscopy, and are referred to the Department of Radiology, AVBRH, Sawangi. Exclusion criteria will encompass patients with prior surgical or medical interventions, pregnant women, individuals with pacemakers or metallic implants, those with psychological conditions or claustrophobia, and those who are unwilling or uncooperative.

Place of study

The study will be conducted at the Department of Radiology, Acharya Vinoba Bhave Rural Hospital, Sawangi, under the auspices of Datta Meghe Institute of Higher Education and Research. AVBRH has the necessary infrastructure and facilities for conducting MRI scans and MR spectroscopy. The hospital serves as a referral center for patients in the region, ensuring access to a diverse patient population for the study.

Inclusion criteria

Exclusion criteria

Enrollment process

Data collection procedure

Data collection for this study will encompass several key components. Initially, baseline information will be gathered, including demographic data such as age, gender, ethnicity, and occupation, alongside a detailed clinical history. This will entail documenting symptoms, their duration, previous treatments, and any existing medical comorbidities. Laboratory investigations will also be recorded, including complete blood count, liver function tests, and tumor markers such as CA 19-9. Moreover, imaging reports from previous studies, such as ultrasounds or CT scans, will be reviewed to compile relevant findings related to gall bladder carcinoma. Subsequently, data collection will focus on MRI and MR spectroscopy. MRI images, including T1-weighted, T2-weighted, and diffusion-weighted images, will be obtained and assessed for various features indicative of gall bladder carcinoma, such as mass lesions or wall thickening. Additionally, MR spectroscopy data will be analyzed for choline peaks, providing quantitative measurements of choline concentration, a potential biomarker for gall bladder carcinoma.

Histopathological data, if available, will also be included in the analysis. This will involve documenting the results of biopsies or surgical specimens, including the histopathological diagnosis of gall bladder carcinoma, tumor grade (well, moderately, or poorly differentiated), and tumor stage based on TNM staging. Followup data will be collected to monitor treatment responses and clinical outcomes. This will entail documenting the treatments received, such as surgery, chemotherapy, or radiotherapy, and assessing responses through radiological evaluations of tumor regression, stabilization, or progression. Additionally, patient survival status, recurrence of carcinoma, and progression-free survival will be recorded.

Furthermore, the study will gather data on patient experiences and any adverse events encountered during MRI and MR spectroscopy procedures. Patient feedback regarding comfort levels and any discomfort or complications experienced will be documented to inform future improvements in patient care. Quality control measures will be implemented throughout the data collection process, including standardized imaging protocols, blinding of radiologists interpreting the data, and regular calibration of imaging equipment to ensure the accuracy and reliability of results. Finally, data management and analysis will involve entering collected data into a secure electronic database and statistical analysis using appropriate methods to examine relationships between variables. Ethical considerations, such as ensuring patient confidentiality, obtaining informed consent, and obtaining institutional review board approval, will be followed throughout the study.

Sample size

Determining the appropriate sample size is crucial for ensuring the study’s statistical power and the reliability of the findings. This study’s sample size calculation was based on the prevalence of gall bladder carcinoma and the desired confidence level and margin of error. Using the Cochran Formula, a sample size of 20 patients was determined, considering a prevalence rate of 1.2% and an error margin of 5%. This sample size provides sufficient statistical power to detect potential associations between MRI findings, choline levels, and gall bladder carcinoma characteristics with high confidence.

Statistical methods

The statistical analysis for this study will employ a range of methods to thoroughly examine the relationships between variables and assess the significance of the findings. Initially, descriptive statistics will be utilized to summarize the characteristics of the study population, encompassing demographic information, clinical features, and imaging findings. Measures such as means, standard deviations, frequencies, and percentages will be calculated to provide a comprehensive overview of the collected data, facilitating a clear understanding of the sample characteristics. Correlation analysis will then explore the strength and direction of relationships between key variables of interest. Specifically, correlations between MRI findings, choline levels measured by MR spectroscopy, and histopathological results will be assessed. Depending on the nature of the data, either Pearson correlation coefficients or Spearman’s rank correlation coefficients will be computed to quantify the degree of association between these variables. Regression analysis will be employed to investigate the predictive value of MRI findings and choline levels for various aspects of gall bladder carcinoma, such as tumor stage, grade, or treatment response. Multiple linear regression or logistic regression models may be utilized to determine the independent contributions of each variable in predicting specific outcomes, thereby elucidating their potential prognostic significance.

Furthermore, comparative analysis will be performed to evaluate differences in MRI findings and choline levels across different subgroups of patients, categorized based on relevant factors such as tumor stage, grade, or treatment status. This analysis will utilize appropriate statistical tests, including t-tests, Mann-Whitney U tests, ANOVA, chi-square tests, or Fisher’s exact tests, depending on the type and distribution of the data. Survival analysis techniques, such as Kaplan-Meier curves and Cox proportional hazards models, may be employed to assess the impact of MRI findings and choline levels on patient survival outcomes, including overall and progression-free survival. These analyses will provide valuable insights into the prognostic significance of imaging biomarkers in gall bladder carcinoma. Additionally, receiver operating characteristic (ROC) analysis may be conducted to evaluate the diagnostic accuracy of MRI findings and choline levels in distinguishing between different stages or grades of gall bladder carcinoma. By calculating the area under the curve (AUC) values, the discriminatory power of these imaging biomarkers can be quantified, informing their clinical utility in disease diagnosis and management using R studio version 4.3.1.

Dissemination

After the completion of the study, we will publish it in an indexed journal or conference.

Study status

The study has yet to start. After the publication of the protocol, we will start recruiting for the study.

Ethical and consent

The Institutional Ethics Committee of Datta Meghe Institute of Higher Education and Research (DU) has approved the study protocol (Reference number: DMIHER/IEC/2023/768. Date: 21-03-2023). Before commencing the study, we will obtain written informed consent from all participants, providing them with a comprehensive explanation of the study’s objectives.