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RECRUITING
NCT06715020
NA

Establishment and Clinical Transformation of ADC Drug Efficacy Evaluation System for Breast Cancer Based on Molecular Imaging

Sponsor: Peking University Cancer Hospital & Institute

View on ClinicalTrials.gov

Summary

The objective of the study is to construct a noninvasive approach 68Ga-TTP PET/CT to detect the TROP2 expression of tumor lesions in patients with breast tumors and evaluate the efficacy of ADC drug therapy.

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

60

Start Date

2024-12-10

Completion Date

2026-12

Last Updated

2026-06-02

Healthy Volunteers

No

Conditions

Interventions

DRUG

18F-FDG

\[18F\]FDG is administered intravenously as the comparator PET radiotracer. In the diagnostic validation cohort, participants undergo one \[18F\]FDG PET examination within 1 week of the \[68Ga\]Ga-TTP scan, with no treatment between scans. In the ADC response assessment cohort, participants undergo \[18F\]FDG PET imaging at the same three time points as \[68Ga\]Ga-TTP: before ADC therapy, after 2 cycles(each cycle is 21 days), and at disease progression. The planned administered activity is approximately 0.1-0.15 mCi/kg.

DRUG

[68Ga]Ga-TTP

\[68Ga\]Ga-TTP is a TROP2-targeted PET radiotracer administered intravenously for PET imaging. In the diagnostic validation cohort, participants undergo one \[68Ga\]Ga-TTP PET examination within 1 week of the comparator \[18F\]FDG scan. In the ADC response assessment cohort, participants undergo \[68Ga\]Ga-TTP PET imaging before ADC therapy, after 2 cycles of treatment(each cycle is 21 days), and at disease progression. The planned administered activity is approximately 0.05-0.1 mCi/kg.

Locations (1)

Peking University Cancer Hospital & Institute

Beijing, China