Target-specific immunoPET Imaging of Digestive System Carcinoma

NCT06715839 | Recruiting DMC

• 1 other identifier: KY2024-107-C
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to establish and optimize the target-specific PET/CT imaging method, and its physiological and pathological distribution characteristics, on the basis of which the diagnostic efficacy of the above imaging agents in digestive system malignant tumors will be evaluated.

Conditions

Colon Cancer; Rectum Cancer; Pancreatic Cancer; Esophagus Cancer; Gallbladder Carcinoma; Small Intestine Cancer; Appendix Cancer; Bile Duct Carcinoma; Malignancy; Digestive Cancer; Digestive System Carcinoma; Digestive System Cancer; Liver Cancer; Stomach Cancer; Digestive System Neoplasm

Keywords

human epidermal growth factor receptor 2 (HER2); Trophoblast cell surface antigen 2 (TROP2); Glypican-3 (GPC3); Glycoprotein A33 (gpA33); Nectin cell adhesion molecule-4 (Nectin-4)

Outcome Measures

Primary Outcomes (5)

• Biodistribution

  Measurement of the overall biodistribution of above tracers in normal tissues and organs.

  1 day from injection of the tracers

• Standardized uptake value (SUV)

  Standardized uptake value (SUV) of above tracers in the included subjects' primary and/or metastatic lesions.

  1 day from injection of the tracers

• Radiation dosimetry

  Measurement of absorbed radiation doses (Gy/MBq) to tissues/organs, tumor(s), and whole body (Sv/MBq). Dynamic imaging within one hour will be acquired for the purpose.

  1 day from injection of the tracers

• Diagnostic value in patients with digestive system malignancy

  Systematic evaluation of these parameters will elucidate the pharmacokinetics, pharmacodynamics and, more importantly, the clinical value of these target-specific tracers in patients with malignancies of the digestive system.

  30 days

• The correlation between the expression of specific target and tracer uptake value

  The Standardized uptake value (SUV) will be calculated, and the correlation between pathological results and tumor uptake of these tracers will be analyzed.

  60 days

Secondary Outcomes (2)

• Predictive value of these tracers in the course of combined immunotherapies and targeted therapies

  3-6 months

• Target-specific PET/CT in changing clinical decision-making for patients with digestive system malignancy

  3-6 months

Study Arms (1)

ImmunoPET imaging in patients with digestive system carcinoma

EXPERIMENTAL

Enrolled patients will undergo a targeted-specific immunoPET/CT scanning.

Drug: [68Ga]Ga-DOTA-H2D3; Drug: [18F]F-RESCA-RB14; Drug: [68Ga]Ga-NOTA-T4; Drug: [18F]F-RESCA-T4; Drug: [68Ga]Ga-NOTA-G5; Drug: [18F]F-RESCA-G5; Drug: [68Ga]Ga-NOTA-WWH347; Drug: [18F]F-RESCA-WWH347; Drug: [68Ga]Ga-NOTA-RND20; Drug: [18F]F-RESCA-RND20

Interventions

[18F]F-RESCA-RB14 DRUG

Enrolled patients (especially those with gastric cancer) will receive 0.05-0.1 mCi/kg of a HER2-targeted probe (\[18F\]F-RESCA-RB14). ImmunoPET/CT imaging will be acquired 1-2 hours after \[18F\]F-RESCA-RB14 injection.

Also known as: [18F]F-RB14

ImmunoPET imaging in patients with digestive system carcinoma

[68Ga]Ga-NOTA-T4 DRUG

Enrolled patients (especially those with gastric cancer/pancreatic cancer) will receive 0.05-0.1 mCi/kg of a Trop2-targeted probe (\[68Ga\]Ga-NOTA-T4). ImmunoPET/CT imaging will be acquired 1-2 hours after \[68Ga\]Ga-NOTA-T4 injection.

Also known as: [68Ga]Ga-T4

ImmunoPET imaging in patients with digestive system carcinoma

[18F]F-RESCA-T4 DRUG

Enrolled patients (especially those with gastric cancer/pancreatic cancer) will receive 0.05-0.1 mCi/kg of a Trop2-targeted probe (\[18F\]F-RESCA-T4). ImmunoPET/CT imaging will be acquired 1-2 hours after \[18F\]F-RESCA-T4 injection.

Also known as: [18F]F-T4

ImmunoPET imaging in patients with digestive system carcinoma

[68Ga]Ga-DOTA-H2D3 DRUG

Enrolled patients (especially those with gastric cancer) will receive 0.05-0.1 mCi/kg of a HER2-targeted probe (\[68Ga\]Ga-DOTA-H2D3). ImmunoPET/CT imaging will be acquired 1-2 hours after \[68Ga\]Ga-DOTA-H2D3 injection.

Also known as: [68Ga]Ga-H2D3

ImmunoPET imaging in patients with digestive system carcinoma

[68Ga]Ga-NOTA-G5 DRUG

Enrolled patients (especially those with hepatocellular carcinoma) will receive 0.05-0.1 mCi/kg of a GPC3-targeted probe (\[68Ga\]Ga-NOTA-G5). ImmunoPET/CT imaging will be acquired 1-2 hours after \[68Ga\]Ga-NOTA-G5 injection.

Also known as: [68Ga]Ga-G5

ImmunoPET imaging in patients with digestive system carcinoma

[18F]F-RESCA-G5 DRUG

Enrolled patients (especially those with hepatocellular carcinoma) will receive 0.05-0.1 mCi/kg of a GPC3-targeted probe (\[18F\]F-RESCA-G5). ImmunoPET/CT imaging will be acquired 1-2 hours after \[18F\]F-RESCA-G5 injection.

Also known as: [18F]F-G5

ImmunoPET imaging in patients with digestive system carcinoma

[68Ga]Ga-NOTA-WWH347 DRUG

Enrolled patients (especially those with colorectal cancer) will receive 0.05-0.1 mCi/kg of a GPA33-targeted probe (\[68Ga\]Ga-NOTA-WWH347). ImmunoPET/CT imaging will be acquired 1-2 hours after \[68Ga\]Ga-NOTA-WWH347 injection.

Also known as: [68Ga]Ga-WWH347

ImmunoPET imaging in patients with digestive system carcinoma

[18F]F-RESCA-WWH347 DRUG

Enrolled patients (especially those with colorectal cancer) will receive 0.05-0.1 mCi/kg of a GPA33-targeted probe (\[18F\]F-RESCA-WWH347). ImmunoPET/CT imaging will be acquired 1-2 hours after \[18F\]F-RESCA-WWH347 injection.

Also known as: [18F]F-WWH347

ImmunoPET imaging in patients with digestive system carcinoma

[68Ga]Ga-NOTA-RND20 DRUG

Enrolled patients will receive 0.05-0.1 mCi/kg of a Nectin-4-targeted probe (\[68Ga\]Ga-NOTA-RND20). ImmunoPET/CT imaging will be acquired 1-2 hours after \[68Ga\]Ga-NOTA-RND20 injection.

Also known as: [68Ga]Ga-RND20

ImmunoPET imaging in patients with digestive system carcinoma

[18F]F-RESCA-RND20 DRUG

Enrolled patients will receive 0.05-0.1 mCi/kg of a Nectin-4-targeted probe (\[18F\]F-RESCA-RND20). ImmunoPET/CT imaging will be acquired 1-2 hours after \[18F\]F-RESCA-RND20 injection.

Also known as: [18F]F-RND20

ImmunoPET imaging in patients with digestive system carcinoma

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged 18-75 years old and of either sex；
• Histologically confirmed diagnosis of digestive system carcinoma or suspected digestive system carcinoma by diagnostic imaging;
• Capable of giving signed informed consent, including compliance with the requirements and restrictions listed in the informed consent form (ICF) and this protocol.

You may not qualify if:

• Pregnancy；
• Severe hepatic and renal insufficiency;
• History of serious surgery in the last month;
• Allergic to antibody or single-domain antibody radiopharmaceuticals.

Sponsors & Collaborators

• RenJi Hospital: lead

Study Sites (1)

Renji Hospital, School of Medicine, Shanghai Jiao Tong University

Shanghai, Shanghai Municipality, 200127, China

RECRUITING

MeSH Terms

Conditions

Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Liver Neoplasms; Stomach Neoplasms; Colonic Neoplasms; Rectal Neoplasms; Pancreatic Neoplasms; Esophageal Neoplasms; Gallbladder Neoplasms; Appendiceal Neoplasms; Bile Duct Neoplasms; Simpson-Golabi-Behmel syndrome

Condition Hierarchy (Ancestors)

Neoplasms by Site; Digestive System Diseases; Gastrointestinal Diseases; Liver Diseases; Stomach Diseases; Colorectal Neoplasms; Intestinal Neoplasms; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Endocrine Gland Neoplasms; Pancreatic Diseases; Endocrine System Diseases; Head and Neck Neoplasms; Esophageal Diseases; Biliary Tract Neoplasms; Biliary Tract Diseases; Gallbladder Diseases; Cecal Neoplasms; Cecal Diseases; Bile Duct Diseases

Study Officials

• Weijun Wei

  Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University

  STUDY CHAIR

Central Study Contacts

Weijun Wei, Ph.D. & M.D.

CONTACT

15000083153; wwei@shsmu.edu.cn

Shuxian An, Ph.D. & M.D.

CONTACT

17717453484; anshuxian@shsmu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 29, 2024
• First Posted: December 4, 2024
• Study Start: December 4, 2024
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: December 31, 2025

Record last verified: 2025-12

Locations

CN (1)