Deep Learning Radiogenomics For Individualized Therapy in Unresectable Gallbladder Cancer

NCT05718115 | Unknown

• 1 other identifier: 31875
• Study Type: observational
• Target: 75
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this observational study is to learn about deep learning radiogenomics for individualized therapy in unresectable gallbladder cancer. The main questions it aims to answer are: (i) whether a deep learning radiomics (DLR) model can be used for identification of HER2status and prediction of response to anti-HER2 directed therapy in unresectable GBC. (ii) validation of the deep learning radiomics (DLR) model for identification of HER2 status and prediction of response to anti-HER2 directed therapy in unresectable GBC. Participants will be asked to

1. 1.Undergo biopsy of the gallbladder mass after a baseline CT scan
2. 2.Based on the results of the biopsy, patients will be given chemotherapy either targeted (if Her2 positive) or non-targeted
3. 3.Response to treatment will be assessed with a CT scan at 12 weeks of chemotherapy

Conditions

Gallbladder Cancer

Keywords

Gallbladder cancer, HER2, Radiogenomics, CT scan

Outcome Measures

Primary Outcomes (2)

• Develop and validate a deep learning radiomics (DLR) model for identification of HER2 status in unresectable gallbladder cancer (GBC) on computed tomography (CT)

  The DLR model identifying HER2 status in unresectable GBC will be developed using contrast enhanced CT scans of 150 patients (retrospective data). The accuracy of DLR will be validated a in a prospective contrast enhanced CT data of 75 patients.

  8 months

• Predict response to anti-HER2 directed therapy using DLR

  DLR will be used to predict response to targeted therapy in prospective cohort of HER2+ GBC patients on follow up CT at 12 weeks using RECIST 1.1

  12 weeks

Interventions

CT scan DIAGNOSTIC_TEST

Biphasic CT scan including arterial phase and portal venous phase after intravenous injection of 80-100 mL of non-ionic iodinated contrast at rate of 4ml/s using pressure injector.

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with unresectable mass-forming GBC

You may qualify if:

• Patients with unresectable mass-forming GBC
• Patients willing to give informed consent

You may not qualify if:

• Patients with prior chemotherapy for GBC
• Patients with deranged RFTs
• Patients with contrast allergy

Sponsors & Collaborators

• Post Graduate Institute of Medical Education and Research, Chandigarh: lead
• Radiological Society of North America: collaborator

Study Sites (1)

Post Graduate Institute of Medical Education and Research

Chandigarh, Punjab, 160012, India

RECRUITING

Related Publications (12)

• Boddapati SB, Lal A, Gupta P, Kalra N, Yadav TD, Gupta V, Dass A, Srinivasan R, Singhal M. Contrast enhanced ultrasound versus multiphasic contrast enhanced computed tomography in evaluation of gallbladder lesions. Abdom Radiol (NY). 2022 Feb;47(2):566-575. doi: 10.1007/s00261-021-03364-6. Epub 2021 Dec 7.

  PMID: 34874479 BACKGROUND

• Gupta P, Dutta U, Rana P, Singhal M, Gulati A, Kalra N, Soundararajan R, Kalage D, Chhabra M, Sharma V, Gupta V, Yadav TD, Kaman L, Irrinki S, Singh H, Sakaray Y, Das CK, Saikia U, Nada R, Srinivasan R, Sandhu MS, Sharma R, Shetty N, Eapen A, Kaur H, Kambadakone A, de Haas R, Kapoor VK, Barreto SG, Sharma AK, Patel A, Garg P, Pal SK, Goel M, Patkar S, Behari A, Agarwal AK, Sirohi B, Javle M, Garcea G, Nervi F, Adsay V, Roa JC, Han HS. Gallbladder reporting and data system (GB-RADS) for risk stratification of gallbladder wall thickening on ultrasonography: an international expert consensus. Abdom Radiol (NY). 2022 Feb;47(2):554-565. doi: 10.1007/s00261-021-03360-w. Epub 2021 Dec 1.

  PMID: 34851429 BACKGROUND

• Rana P, Gupta P, Kalage D, Soundararajan R, Kumar-M P, Dutta U. Grayscale ultrasonography findings for characterization of gallbladder wall thickening in non-acute setting: a systematic review and meta-analysis. Expert Rev Gastroenterol Hepatol. 2022 Jan;16(1):59-71. doi: 10.1080/17474124.2021.2011210. Epub 2022 Jan 17.

  PMID: 34826262 BACKGROUND

• Gupta P, Rana P, Ganeshan B, Kalage D, Irrinki S, Gupta V, Yadav TD, Kumar R, Das CK, Gupta P, Endozo R, Nada R, Srinivasan R, Kalra N, Dutta U, Sandhu M. Computed tomography texture-based radiomics analysis in gallbladder cancer: initial experience. Clin Exp Hepatol. 2021 Dec;7(4):406-414. doi: 10.5114/ceh.2021.111173. Epub 2021 Dec 2.

  PMID: 35402717 BACKGROUND

• Gupta P, Marodia Y, Bansal A, Kalra N, Kumar-M P, Sharma V, Dutta U, Sandhu MS. Imaging-based algorithmic approach to gallbladder wall thickening. World J Gastroenterol. 2020 Oct 28;26(40):6163-6181. doi: 10.3748/wjg.v26.i40.6163.

  PMID: 33177791 BACKGROUND

• Gupta P, Kumar M, Sharma V, Dutta U, Sandhu MS. Evaluation of gallbladder wall thickening: a multimodality imaging approach. Expert Rev Gastroenterol Hepatol. 2020 Jun;14(6):463-473. doi: 10.1080/17474124.2020.1760840. Epub 2020 Apr 30.

  PMID: 32323586 BACKGROUND

• Gupta P, Meghashyam K, Marodia Y, Gupta V, Basher R, Das CK, Yadav TD, Irrinki S, Nada R, Dutta U. Locally advanced gallbladder cancer: a review of the criteria and role of imaging. Abdom Radiol (NY). 2021 Mar;46(3):998-1007. doi: 10.1007/s00261-020-02756-4. Epub 2020 Sep 18.

  PMID: 32945922 BACKGROUND

• Kalra N, Gupta P, Singhal M, Gupta R, Gupta V, Srinivasan R, Mittal BR, Dhiman RK, Khandelwal N. Cross-sectional Imaging of Gallbladder Carcinoma: An Update. J Clin Exp Hepatol. 2019 May-Jun;9(3):334-344. doi: 10.1016/j.jceh.2018.04.005. Epub 2018 Apr 30.

  PMID: 31360026 BACKGROUND

• Javle M, Borad MJ, Azad NS, Kurzrock R, Abou-Alfa GK, George B, Hainsworth J, Meric-Bernstam F, Swanton C, Sweeney CJ, Friedman CF, Bose R, Spigel DR, Wang Y, Levy J, Schulze K, Cuchelkar V, Patel A, Burris H. Pertuzumab and trastuzumab for HER2-positive, metastatic biliary tract cancer (MyPathway): a multicentre, open-label, phase 2a, multiple basket study. Lancet Oncol. 2021 Sep;22(9):1290-1300. doi: 10.1016/S1470-2045(21)00336-3. Epub 2021 Jul 30.

  PMID: 34339623 BACKGROUND

• Javle M, Churi C, Kang HC, Shroff R, Janku F, Surapaneni R, Zuo M, Barrera C, Alshamsi H, Krishnan S, Mishra L, Wolff RA, Kaseb AO, Thomas MB, Siegel AB. HER2/neu-directed therapy for biliary tract cancer. J Hematol Oncol. 2015 May 29;8:58. doi: 10.1186/s13045-015-0155-z.

  PMID: 26022204 BACKGROUND

• Albrecht T, Rausch M, Roessler S, Geissler V, Albrecht M, Halske C, Seifert C, Renner M, Singer S, Mehrabi A, Vogel MN, Pathil-Warth A, Busch E, Kohler B, Rupp C, Weiss KH, Springfeld C, Rocken C, Schirmacher P, Goeppert B. HER2 gene (ERBB2) amplification is a low-frequency driver with potential predictive value in gallbladder carcinoma. Virchows Arch. 2020 Jun;476(6):871-880. doi: 10.1007/s00428-019-02706-6. Epub 2019 Dec 14.

  PMID: 31838585 BACKGROUND

• May M, Raufi AG, Sadeghi S, Chen K, Iuga A, Sun Y, Ahmed F, Bates S, Manji GA. Prolonged Response to HER2-Directed Therapy in Three Patients with HER2-Amplified Metastatic Carcinoma of the Biliary System: Case Study and Review of the Literature. Oncologist. 2021 Aug;26(8):640-646. doi: 10.1002/onco.13800. Epub 2021 May 11.

  PMID: 33896096 BACKGROUND

MeSH Terms

Conditions

Gallbladder Neoplasms

Interventions

Tomography, X-Ray Computed

Condition Hierarchy (Ancestors)

Biliary Tract Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Biliary Tract Diseases; Digestive System Diseases; Gallbladder Diseases

Intervention Hierarchy (Ancestors)

Image Interpretation, Computer-Assisted; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Radiographic Image Enhancement; Image Enhancement; Photography; Radiography; Tomography, X-Ray; Tomography

Study Officials

• Pankaj Gupta

  PGIMER, CHANDIGARH

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Pankaj Gupta

CONTACT

0172-2756508; pankajgupta959@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: January 29, 2023
• First Posted: February 8, 2023
• Study Start: February 15, 2023
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: February 8, 2023

Record last verified: 2023-02

Locations

IN (1)