NCT04941872

Comparison of 68Ga-DOTA-FAPI-46 and 68Ga-DOTA-2P(FAPI)2 PET/CT in Patients With Various Types of Cancer

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 7 (actual)
• Sponsor: The First Affiliated Hospital of Xiamen University · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

To evaluate the potential usefulness of 68Ga-DOTA-2P(FAPI)2 positron emission tomography/computed tomography (PET/CT) for the diagnosis of primary and metastatic lesions in various types of cancer, compared with 68Ga-DOTA-FAPI-46 PET/CT.

Detailed description

In order to enhance the tumor uptake and tumor retention time, we designed the dimer structure of fibroblast activation protein inhibitor (FAPI), a novel imaging agent that targeting cancer-associated fibroblasts expressed in various types of cancer, 68Ga-DOTA-2P(FAPI)2. Subjects with various types of cancer underwent contemporaneous 68Ga-DOTA-2P(FAPI)2 and 68Ga-DOTA-FAPI-46 PET/CT either for an initial assessment or for recurrence detection. Tumor uptake was quantified by the maximum standard uptake value (SUVmax). The sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV) and accuracy of 68Ga-DOTA-FAPI-46 and 68Ga-DOTA-2P(FAPI)2 PET/CT were calculated and compared to evaluate the diagnostic efficacy.

Conditions

• Tumor, Solid, FAPI, PET/CT, Metastasis

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	68Ga-DOTA-FAPI-46 and 68Ga-DOTA-2P(FAPI)2 PET/CT	Each subject receive a single intravenous injection of 68Ga-DOTA-FAPI-46 and 68Ga-DOTA-2P(FAPI)2, and undergo PET/CT imaging within the specified time.

Timeline

• Start date: 2021-06-18
• Primary completion: 2022-06-24
• Completion: 2022-11-01
• First posted: 2021-06-28
• Last updated: 2023-08-08

Locations

1 site across 1 country: China