Trop2-targeted immunoPET Imaging of Solid Tumors

May 27, 2026 updated by: RenJi Hospital
This study aims to establish and optimize the trophoblast cell surface antigen 2 (Trop2)-targeted immuno-positron emission tomography/computed tomography (immunoPET/CT) imaging method and its physiological and pathological distribution characteristics, based on which the diagnostic efficacy of the above imaging agents in solid tumors (including uroepithelial cancer, bladder cancer, prostate cancer, lung cancer, nasopharyngeal cancer, liver cancer, cholangiocarcinoma, ovarian cancer, cervical cancer, endometrial cancer, thyroid cancer, head and neck cancer) will be evaluated.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Histologically confirmed solid tumors (including uroepithelial cancer, bladder cancer, prostate cancer, lung cancer, nasopharyngeal cancer, liver cancer, cholangiocarcinoma, ovarian cancer, cervical cancer, endometrial cancer, thyroid cancer, head and neck cancer), or patients with suspected solid tumors (including uroepithelial cancer, bladder cancer, prostate cancer, lung cancer, nasopharyngeal cancer, liver cancer, cholangiocarcinoma, ovarian cancer, cervical cancer, endometrial cancer, thyroid cancer, head and neck cancer) indicated by conventional diagnostic imaging will be included. Patients will also be included for routine follow-up, surveillance, and treatment efficacy evaluation.For patients with prostate cancer or suspected prostate cancer, head-to-head comparisons with PSMA PET are still needed.

Enrolled patients will undergo whole-body immunoPET/CT scans 1-2 hours after tracer injection (0.05-0.1 mCi/kg). The uptake of imaging tracers in tumors 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 assess the diagnostic efficacy. The correlation between lesion uptake and Trop2 expression level determined by immunohistochemistry staining will be further analyzed. The primary exploration endpoint will be the tracers' imaging feasibility and preliminary diagnostic value compared to conventional imaging approaches like 18F-FDG PET/CT.

Study Type

Interventional

Enrollment (Estimated)

400

Phase

  • Phase 2
  • Phase 3

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

Study Locations

  • China
      • Shanghai, China, 200127
        • Recruiting
        • Renji Hospital, School of Medicine, Shanghai Jiao Tong University
        • Contact:
        • Contact:

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.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Aged 18-75 year-old and of either sex
  • Histologically confirmed diagnosis of solid tumors (including uroepithelial cancer, bladder cancer, prostate cancer, lung cancer, nasopharyngeal cancer, liver cancer, cholangiocarcinoma, ovarian cancer, cervical cancer, endometrial cancer, thyroid cancer, head and neck cancer) or suspected solid tumors (including uroepithelial cancer, bladder cancer, prostate cancer, lung cancer, nasopharyngeal cancer, liver cancer, cholangiocarcinoma, ovarian cancer, cervical cancer, endometrial cancer, thyroid cancer, head and neck cancer) by diagnostic imaging;
  • Capable of giving signed informed consent, including compliance with the requirements and restrictions in the informed consent form (ICF) and this protocol.

Exclusion Criteria:

  • Pregnancy；
  • Severe hepatic and renal insufficiency;
  • Allergic to single-domain antibody radiopharmaceuticals.

Study Plan

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

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Trop2-targeted immunoPET imaging
Enrolled patients will undergo a Trop2-targeted immunoPET/CT scanning.
Drug: [68Ga]Ga-NOTA-T4
Enrolled patients will receive 0.05-0.1 mCi/kg of [68Ga]Ga-NOTA-T4. ImmunoPET/CT imaging will be acquired 1-2 hours after [68Ga]Ga-NOTA-T4 injection.
Other Names:
  • [68Ga]T4
Drug: [68Ga]Ga-NOTA-RT4
Enrolled patients will receive 0.05-0.1 mCi/kg of [68Ga]Ga-NOTA-RT4. ImmunoPET/CT imaging will be acquired 1-2 hours after [68Ga]Ga-NOTA-RT4 injection.
Other Names:
  • [68Ga]RT4
Drug: [18F]F-RESCA-T4
Enrolled patients will receive 0.05-0.1 mCi/kg of [18F]F-RESCA-T4. ImmunoPET/CT imaging will be acquired 1-2 hours after [18F]F-RESCA-T4 injection.
Other Names:
  • [18F]T4
Drug: [18F]F-RESCA-RT4
Enrolled patients will receive 0.05-0.1 mCi/kg of [18F]F-RESCA-RT4. ImmunoPET/CT imaging will be acquired 1-2 hours after [18F]F-RESCA-RT4 injection.
Other Names:
  • [18F]RT4

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
SUV of tumors
Time Frame: 1 day from injection of the tracers
The SUV of the above tracers in the primary and/or metastatic lesions of the included subjects. To calculate the SUV, circular regions of interest were drawn around the area of focally increased uptake in the transaxial slices and automatically fitted to a three-dimensional volume of interest.
1 day from injection of the tracers
Radiation dosimetry of tissues/organs
Time Frame: 1 day from injection of the tracers
Measurement of absorbed radiation doses (Gy/MBq) to tissues/organs. The following tissues were included: adrenals, brain, breasts, gallbladder, small intestine, upper and lower large intestine, stomach, heart contents, heart muscle, kidney, liver, lung, muscle, ovaries, pancreas, red marrow, trabecular and cortical bone, spleen, testes, thymus, thyroid, urinary bladder, and uterus. Dynamic imaging within one hour will be performed for this purpose.
1 day from injection of the tracers
Radiation dosimetry of tumors
Time Frame: 1 day from injection of the tracers
Measurement of absorbed radiation doses (Gy/MBq) to tumors. Dynamic imaging within one hour will be performed for this purpose.
1 day from injection of the tracers
Radiation dosimetry of whole-body
Time Frame: 1 day from injection of the tracers
Whole-body activity was measured using a large volume of interest (VOI) covering the entire subject.
1 day from injection of the tracers
Biodistribution-Standardized uptake value (SUV) of normal tissues and organs.
Time Frame: 1 day from injection of the tracers
Measurement of the overall biodistribution of the above tracers in normal tissues and organs (bladder (after voiding), background (pelvic fat), blood, brain, salivary and lacrimal glands, lung, liver, spleen, pancreas, small intestine, and kidneys). To calculate the SUV, circular regions of interest were drawn around the area of focally increased uptake in the transaxial slices and automatically fitted to a three-dimensional volume of interest.
1 day from injection of the tracers
Diagnostic sensitivity
Time Frame: 30 days
Sensitivity = (True Positives) / (True Positives + False Negatives). The diagnostic value of Trop2 immunoPET/CT will be compared with that of conventional imaging approaches, including 18F-FDG PET/CT, CT, and MRI.
30 days
Diagnostic specificity
Time Frame: 30 days
Specificity = (True Negatives) / (True Negatives + False Positives). The diagnostic value of Trop2 immunoPET/CT will be compared with that of conventional imaging approaches, including 18F-FDG PET/CT, CT, and MRI.
30 days
Accuracy
Time Frame: 30 days
Accuracy = (True Positives + True Negatives) / (Total Tests). The diagnostic value of Trop2 immunoPET/CT will be compared with that of conventional imaging approaches, including 18F-FDG PET/CT, CT, and MRI.
30 days
Positive Predictive Value (PPV)
Time Frame: 30 days
PPV = (True Positives) / (True Positives + False Positives). The diagnostic value of Trop2 immunoPET/CT will be compared with that of conventional imaging approaches, including 18F-FDG PET/CT, CT, and MRI.
30 days
Negative Predictive Value (NPV)
Time Frame: 30 days
NPV = (True Negatives) / (True Negatives + False Negatives). The diagnostic value of Trop2 immunoPET/CT will be compared with that of conventional imaging approaches, including 18F-FDG PET/CT, CT, and MRI.
30 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Trop2 immunoPET/CT in altering initial staging for patients with solid tumors
Time Frame: 3-6 months
Assess the role of Trop2 immunoPET/CT in initial staging in terms of the number of metastases.
3-6 months
Trop2 immunoPET/CT for postoperative surveillance for patients with solid tumors
Time Frame: 3-6 months
Assess the role of Trop2 immunoPET/CT in surveillance in terms of the number of metastases, Trop2-derived tumor volume (Trop2-TV), and total lesion Trop2 uptake (Trop2-TLU).
3-6 months
Trop2 immunoPET/CT for restaging for patients with solid tumors
Time Frame: 3-6 months
Assess the role of Trop2 immunoPET/CT in restaging in terms of the number of metastases, Trop2-TV, and Trop2-TLU.
3-6 months
Trop2 immunoPET/CT in evaluating treatment responses
Time Frame: 1-2 years
We will also investigate the role of Trop2 immunoPET/CT in predicting and evaluating the treatment efficacy in patients with solid tumors (including uroepithelial cancer, bladder cancer, prostate cancer, lung cancer, nasopharyngeal cancer, liver cancer, cholangiocarcinoma, ovarian cancer, cervical cancer, endometrial cancer, thyroid cancer, head and neck cancer). The treatment regimens vary for different tumor types but involve chemotherapy, molecularly targeted therapies, immunotherapies (e.g. PD-1/PD-L1 inhibitors), and cell therapies.
1-2 years
Whole-body tumor burden（Trop2/PSMA-TV and TL-Trop2/PSMA）
Time Frame: 30 days
For patients with prostate cancer or suspected prostate cancer, we will investigate the association between Trop2-derived and PSMA-derived volumetric parameters by correlating their respective values obtained from [18F]AlF-RESCA-RT4 and PSMA PET
30 days

Collaborators and Investigators

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

Sponsor

RenJi Hospital

Investigators

  • Principal Investigator: Weijun Wei, Ph.D. & M.D., Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University
  • Study Chair: Jianjun Liu, Ph.D. & M.D., Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University

Publications and helpful links

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

General Publications

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 Major Dates

Study Start (Actual)

December 23, 2024

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

December 1, 2027

Study Registration Dates

First Submitted

February 24, 2025

First Submitted That Met QC Criteria

February 24, 2025

First Posted (Actual)

February 28, 2025

Study Record Updates

Last Update Posted (Actual)

May 29, 2026

Last Update Submitted That Met QC Criteria

May 27, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LY2024-307-A

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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