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Target-specific immunoPET Imaging of Digestive System Carcinoma

NCT ID: NCT06715839

Last Updated: 2025-12-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

400 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-12-04

Study Completion Date

2027-09-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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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

Keywords

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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)

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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ImmunoPET imaging in patients with digestive system carcinoma

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

Group Type EXPERIMENTAL

[68Ga]Ga-DOTA-H2D3

Intervention Type 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.

[18F]F-RESCA-RB14

Intervention Type 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.

[68Ga]Ga-NOTA-T4

Intervention Type 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.

[18F]F-RESCA-T4

Intervention Type 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.

[68Ga]Ga-NOTA-G5

Intervention Type 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.

[18F]F-RESCA-G5

Intervention Type 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.

[68Ga]Ga-NOTA-WWH347

Intervention Type 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.

[18F]F-RESCA-WWH347

Intervention Type 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.

[68Ga]Ga-NOTA-RND20

Intervention Type 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.

[18F]F-RESCA-RND20

Intervention Type 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.

Interventions

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[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.

Intervention Type 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.

Intervention Type 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.

Intervention Type 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.

Intervention Type 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.

Intervention Type 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.

Intervention Type 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.

Intervention Type 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.

Intervention Type 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.

Intervention Type 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.

Intervention Type DRUG

Other Intervention Names

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[68Ga]Ga-H2D3 [18F]F-RB14 [68Ga]Ga-T4 [18F]F-T4 [68Ga]Ga-G5 [18F]F-G5 [68Ga]Ga-WWH347 [18F]F-WWH347 [68Ga]Ga-RND20 [18F]F-RND20

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

1. Pregnancy；
2. Severe hepatic and renal insufficiency;
3. History of serious surgery in the last month;
4. Allergic to antibody or single-domain antibody radiopharmaceuticals.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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RenJi Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Weijun Wei

Role: STUDY_CHAIR

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

Locations

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Renji Hospital, School of Medicine, Shanghai Jiao Tong University

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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

Role: CONTACT

Phone: 15000083153

Email: [email protected]

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

Role: CONTACT

Phone: 17717453484

Email: [email protected]

Facility Contacts

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

Role: primary

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

Role: backup

Other Identifiers

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KY2024-107-C

Identifier Type: -

Identifier Source: org_study_id