ImmunoPET Targeting Trophoblast Cell-surface Antigen 2 (Trop-2) in Solid Tumors

ImmunoPET Targeting Trophoblast Cell-surface Antigen 2 (Trop-2) in Solid Tumors and Compared With 18F-FDG

The objective of the study is to construct a noninvasive approach 68Ga-THP-Trop2 VHH PET/CT to detect the Trop-2 expression of tumor lesions in patients with Solid tumors and to identify patients benefiting from Trop-2 targeting antibody-drug conjugate treatment.

Study Overview

• Status: Recruiting
• Conditions: Solid Tumor; Tumor; Positron-Emission Tomography
• Intervention / Treatment: Diagnostic test: standard-of-care imaging (18F-FDG, 68Ga-PSMA, or 68Ga-DOTATATE PET/CT), 68Ga-THP-Trop2 VHH PET/CT

Detailed Description

As a new trophoblast cell-surface antigen 2 (Trop-2) targeting PET radiotracer, 68Ga-THP-Trop2 VHH is promising as an excellent imaging agent applicable to various cancers. In this research, subjects with various types of tumors underwent contemporaneous 68Ga-THP-Trop2 VHH and standard-of-care imaging (18F-FDG, 68Ga-PSMA, or 68Ga-DOTATATE PET/CT) either for an initial assessment or for recurrence detection. Tumor uptake was quantified by the maximum standard uptake value (SUVmax). The numbers of positive tumor lesions of standard-of-care imaging and 68Ga-THP-Trop2 VHH PET/CT were recorded by visual interpretation. The diagnostic accuracy of 68Ga-THP-Trop2 VHH was calculated and compared to standard-of-care imaging.

• Study Type: Interventional
• Enrollment (Estimated): 90
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Haojun Chen; Phone Number: +8618659285282; Email: leochen0821@foxmail.com

Study Locations

• China
  • Fujian
    • Xiamen, Fujian, China, 361003
      • Recruiting
      • The First Affiliated Hospital of Xiamen University
      • Contact: Haojun Chen; Phone Number: +8618659285282; Email: leochen0821@foxmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. adult patients (aged 18 years or order);
2. patients with suspected or newly diagnosed or previously treated malignant tumors (supporting evidence may include MRI, CT, tumor markers and pathology report);
3. patients who had scheduled both standard-of-care imaging (18F-FDG, 68Ga-PSMA, or 68Ga-DOTATATE PET/CT) and 68Ga-THP-Trop2 VHH PET/CT scans;
4. patients who were able to provide informed consent (signed by participant, parent or legal representative) and assent according to the guidelines of the Clinical Research Ethics Committee.

Exclusion Criteria:

1. patients with pregnancy;
2. the inability or unwillingness of the research participant, parent or legal representative to provide written informed consent.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 68Ga-THP-Trop2 VHH; Each subject receives a single intravenous injection of 68Ga-THP-Trop2 VHH and undergoes PET/CT imaging within the specified time.	Diagnostic test: standard-of-care imaging (18F-FDG, 68Ga-PSMA, or 68Ga-DOTATATE PET/CT), 68Ga-THP-Trop2 VHH PET/CT; Each subject receives a single intravenous injection of standard-of-care imaging radiopharmaceuticals (18F-FDG, 68Ga-PSMA, or 68Ga-DOTATATE) and 68Ga-THP-Trop2 VHH, and undergoes PET/CT imaging within the specified time.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Diagnostic efficacy	The sensitivity, specificity, and accuracy of standard-of-care imaging (18F-FDG, 68Ga-PSMA, or 68Ga-DOTATATE PET/CT) and 68Ga-THP-Trop2 VHH PET/CT were calculated and compared to evaluate the diagnostic accuracy.	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of lesions	The numbers of positive primary and metastatic lesions of standard-of-care imaging (18F-FDG, 68Ga-PSMA, or 68Ga-DOTATATE PET/CT) and 68Ga-THP-Trop2 VHH PET/CT were recorded by visual interpretation.	2 years
SUV	Standardized uptake value (SUV) of standard-of-care imaging (18F-FDG, 68Ga-PSMA, or 68Ga-DOTATATE PET/CT) and 68Ga-THP-Trop2 VHH PET/CT for each target lesion of subject or suspected primary tumor or/and metastasis.	2 years

Collaborators and Investigators

• Sponsor: The First Affiliated Hospital of Xiamen University

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2023
• Primary Completion (Estimated): October 1, 2024
• Study Completion (Estimated): October 1, 2025

Study Registration Dates

• First Submitted: December 18, 2023
• First Submitted That Met QC Criteria: December 18, 2023
• First Posted (Actual): January 3, 2024

Study Record Updates

• Last Update Posted (Actual): April 16, 2024
• Last Update Submitted That Met QC Criteria: April 14, 2024
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: Diagnosis; Positron-Emission Tomography; Tumor; Trop-2; Solid
• Additional Relevant MeSH Terms: Neoplasms; Molecular Mechanisms of Pharmacological Action; Radiopharmaceuticals; Gallium 68 PSMA-11
• Other Study ID Numbers: XMYY-2023KY146

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No