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

Solid Tumor Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06188468
• Other study ID #: XMYY-2023KY146
• Status: Recruiting
• Phase: N/A
• Start date: October 1, 2023
• Est. completion date: October 1, 2025

Study information

• Verified date: December 2023
• Source: The First Affiliated Hospital of Xiamen University
• Contact: Haojun Chen
• Phone: +8618659285282
• Email: leochen0821[@]foxmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: October 1, 2025
• Est. primary completion date: October 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Neoplasms
• Positron-Emission Tomography
• Solid Tumor
• Tumor

Intervention

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.

Locations

Country	Name	City	State
China	The First Affiliated Hospital of Xiamen University	Xiamen	Fujian

Sponsors (1)

Lead Sponsor	Collaborator
The First Affiliated Hospital of Xiamen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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