68Ga-FAPI PET/CT in Patients With Various Types of Cancer

Early Phase 1

• Conditions: Tumor; Positron-Emission Tomography; Metastasis
• Interventions: Drug: 68Ga-DOTA/NOTA-FAPI-04; Diagnostic Test: PET/CT scan

• Registration Number: NCT04499365
• Lead Sponsor: First Affiliated Hospital of Fujian Medical University

Brief Summary

To evaluate the potential usefulness of 68Ga-DOTA/NOTA-FAPI-04 positron emission tomography/computed tomography (PET/CT) for the diagnosis of primary and metastatic lesions in various types of cancer.

Detailed Description

Subjects with various types of cancer underwent 68Ga-DOTA/NOTA-FAPI-04 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/NOTA-FAPI-04 PET/CT were calculated.

Study Timeline

• Study First Submitted: 2020-08-01
• Study First Submitted QC: 2020-08-04
• Study First Posted: 2020-08-05
• Study Start: 2020-08-15
• Status Verified: 2020-09
• Last Update Submitted: 2020-09-05
• Last Update Posted: 2020-09-09
• Primary Completion: 2023-12-30
• Study Completion: 2023-12-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

• (i) adult patients (aged 18 years or order); (ii) patients with suspected or new diagnosed or previously treated malignant tumors (supporting evidence may include MRI, CT, tumor markers and pathology report); (iii) patients who had scheduled 68Ga-DOTA/NOTA-FAPI-04 PET/CT scan; (iv) 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

• (i) patients with non-malignant lesions; (ii) patients with pregnancy; (iii) the inability or unwillingness of the research participant, parent or legal representative to provide written informed consent.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Experimental: 68Ga-DOTA/NOTA-FAPI-04	PET/CT scan	Each subject receive a single intravenous injection of 68Ga-DOTA/NOTA-FAPI-04, and undergo PET/CT imaging within the specificed time.
Experimental: 68Ga-DOTA/NOTA-FAPI-04	68Ga-DOTA/NOTA-FAPI-04	Each subject receive a single intravenous injection of 68Ga-DOTA/NOTA-FAPI-04, and undergo PET/CT imaging within the specificed time.

Primary Outcome Measures

Name	Time	Method
Standardized uptake value (SUV)	30 days	Standardized uptake value (SUV) of 68Ga-DOTA/NOTA-FAPI-04 for each target lesion of subject or suspected primary tumor or/and metastasis.

Secondary Outcome Measures

Name	Time	Method
Diagnostic efficacy	30 days	The positive predictive value (PPV), negative predictive value (NPV)

Trial Locations

Locations (1)

The First Affiliated Hospital of Fujian Medical University; 🇨🇳 Fuzhou, Fujian, China