Target-specific ImmunoPET Imaging Of Digestive System Carcinoma

Study Overview

Target-specific immunoPET Imaging of Digestive System Carcinoma

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.

Enrolled patients will undergo whole-body PET/CT scans at 1 hours after tracer injection(0.05-0.1 mCi/kg). Uptake of above imaging agents in tumor and normal organs/tissues will be scored visually and quantitatively. Tumor uptake will be quantified by the maximum standard uptake value (SUVmax). The sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), and accuracy will be calculated to evaluate the diagnostic efficacy. The correlation between lesion uptake and protein expression level determined by immunohistochemistry staining will be further analyzed. The exploration endpoint will be the imaging feasibility and preliminary diagnostic value of the above tracers.

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

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

KY2024-107-C

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2024-11-29	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2024-11-29
First Submitted that Met QC Criteria 2024-11-29	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2024-12-04
First Posted (ACTUAL) 2024-12-04	Results First Posted N/A	Last Verified 2024-11

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Diagnostic

Allocation:
Na

Interventional Model:
Single Group

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: ImmunoPET imaging in patients with digestive system carcinoma Enrolled patients will undergo a targeted-specific immunoPET/CT scanning.	DRUG: [68Ga]Ga-DOTA-H2D3 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. DRUG: [18F]F-RESCA-RB14 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. DRUG: [68Ga]Ga-NOTA-T4 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. DRUG: [18F]F-RESCA-T4 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. DRUG: [68Ga]Ga-NOTA-G5 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. DRUG: [18F]F-RESCA-G5 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. DRUG: [68Ga]Ga-NOTA-WWH347 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. DRUG: [18F]F-RESCA-WWH347 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. DRUG: [68Ga]Ga-NOTA-RND20 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. DRUG: [18F]F-RESCA-RND20 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.

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: ImmunoPET imaging in patients with digestive system carcinoma

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

DRUG: [68Ga]Ga-DOTA-H2D3

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.

DRUG: [18F]F-RESCA-RB14

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.

DRUG: [68Ga]Ga-NOTA-T4

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.

DRUG: [18F]F-RESCA-T4

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.

DRUG: [68Ga]Ga-NOTA-G5

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.

DRUG: [18F]F-RESCA-G5

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.

DRUG: [68Ga]Ga-NOTA-WWH347

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.

DRUG: [18F]F-RESCA-WWH347

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.

DRUG: [68Ga]Ga-NOTA-RND20

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.

DRUG: [18F]F-RESCA-RND20

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.

Primary Outcome Measures	Measure Description	Time Frame
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 Outcome Measures	Measure Description	Time Frame
Predictive value of these tracers in the course of combined immunotherapies and targeted therapies	Baseline and follow-up immunoPET imaging in combined immunotherapies and targeted therapies (four to eight cycles) will be investigated in this setting to determine the value of the immunoPET imaging in predicting or evaluating treatment responses.	3-6 months
Target-specific PET/CT in changing clinical decision-making for patients with digestive system malignancy	After analyzing the imaging parameters and diagnostic/predictive value of these target-specific tracers, we will also investigate how clinical use of these tracers changes clinical decision-making for patients with malignant tumors of the digestive system. Joint efforts from nuclear medicine physicians, surgeons, oncologists, and pathologists will draw solid conclusions from the imaging and clinical information.	3-6 months

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

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

Phone Number: 15000083153

Email: wwei@shsmu.edu.cn

Study Contact Backup

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

Phone Number: 17717453484

Email: anshuxian@shsmu.edu.cn

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

STUDY_CHAIR: Weijun Wei, Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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