Target-specific immunoPET Imaging of Digestive System Carcinoma

Not Applicable

Recruiting

• Conditions: Malignancy; Digestive Cancer; Digestive System Neoplasm; Digestive System Carcinoma; Digestive System Cancer; Liver Cancer; Stomach Cancer; Colon Cancer; Rectum Cancer; Pancreatic Cancer
• Interventions: 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

• Registration Number: NCT06715839
• Lead Sponsor: RenJi Hospital

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.

Detailed Description

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.

Study Timeline

• Study Start: 2024-09-12
• Status Verified: 2024-11
• Study First Submitted: 2024-11-29
• Study First Submitted QC: 2024-11-29
• Last Update Submitted: 2024-11-29
• Study First Posted: 2024-12-04
• Last Update Posted: 2024-12-04
• Primary Completion: 2027-09
• Study Completion: 2027-09

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 400

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Biodistribution	1 day from injection of the tracers	Measurement of the overall biodistribution of above tracers in normal tissues and organs.
Standardized uptake value (SUV)	1 day from injection of the tracers	Standardized uptake value (SUV) of above tracers in the included subjects' primary and/or metastatic lesions.
Radiation dosimetry	1 day from injection of the tracers	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.
Diagnostic value in patients with digestive system malignancy	30 days	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.
The correlation between the expression of specific target and tracer uptake value	60 days	The Standardized uptake value (SUV) will be calculated, and the correlation between pathological results and tumor uptake of these tracers will be analyzed.

Secondary Outcome Measures

Name	Time	Method
Predictive value of these tracers in the course of combined immunotherapies and targeted therapies	3-6 months	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.
Target-specific PET/CT in changing clinical decision-making for patients with digestive system malignancy	3-6 months	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.

Trial Locations

Locations (1)

Renji Hospital, School of Medicine, Shanghai Jiao Tong University; 🇨🇳 Shanghai, Shanghai, China