Actively Recruiting

Phase Not Applicable
Age: 18Years - 75Years
All Genders
ID06715839

Development and Clinical Translation of immunoPET Imaging Probes for Digestive System Carcinoma

Led by RenJi Hospital · Updated on 2025-12-31

400

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating target-specific immunoPET/CT imaging methods for digestive system carcinomas, including various malignant tumors in the digestive tract. This study aims to establish optimal imaging techniques and understand the physiological and pathological distribution of these imaging agents. The diagnostic effectiveness of these agents will be assessed, focusing on their ability to detect malignant tumors in the digestive system. Participants will receive one of several target-specific radioactive probes designed to highlight cancer cells during PET/CT scans. These probes include HER2-targeted, Trop2-targeted, GPC3-targeted, GPA33-targeted, and Nectin-4-targeted agents, each given at a dose of 0.05-0.1 mCi/kg. Whole-body PET/CT scans will be performed 1 to 2 hours after injection to visualize tumor uptake, which will be scored both visually and quantitatively. During the study, researchers will measure the distribution of the tracers in the body, including maximum standardized uptake values (SUVmax) in tumors. They will evaluate diagnostic accuracy by calculating sensitivity, specificity, and predictive values, and correlate tracer uptake with protein expression in tumor tissue. Secondary outcomes include the tracers' predictive value for immunotherapies and targeted therapies over 3 to 6 months. Participants will be monitored for radiation dosimetry and safety, with study participation lasting up to several months depending on outcomes assessed.

CONDITIONS

Brief Title

Target-specific immunoPET Imaging of Digestive System Carcinoma

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Aged 18-75 years old and of either sex
  • Histologically confirmed diagnosis of digestive system carcinoma or suspected digestive system carcinoma by diagnostic imaging
  • Able to give signed informed consent and comply with study requirements
Not Eligible

You will not qualify if you...

  • Pregnant
  • Severe liver or kidney failure
  • History of serious surgery in the last month
  • Allergy to antibody or single-domain antibody radiopharmaceuticals

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

Duration - 1 day

Participants receive a targeted-specific immunoPET/CT scan 1 to 2 hours after injection of a radioactive tracer targeting specific proteins related to digestive system carcinoma.

1 imaging visit (in-person)

Long-term Monitoring

Duration - Up to 6 months

Participants are monitored to evaluate diagnostic value, correlation between tracer uptake and target expression, and predictive value in therapy response over several months.

Follow-up visits over 3 to 6 months

Trial Site Locations

Total: 1 location

1

Renji Hospital, School of Medicine, Shanghai Jiao Tong University

Shanghai, Shanghai Municipality, China, 200127

Actively Recruiting

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Research Team

W

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

S

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

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

DIAGNOSTIC

Number of Arms

1

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