Study of 64Cu-FAPI-XT117 PET/CT in Patients With Malignant Solid Tumors

Malignant Solid Tumors Clinical Trial

Official title:

Study of 64Cu-FAPI-XT117 PET/CT in Patients With Malignant Solid Tumors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05930457
• Other study ID #: XT-XTR016-1-02
• Status: Completed
• Phase: Phase 1
• Start date: July 26, 2023
• Est. completion date: December 18, 2023

Study information

• Verified date: December 2023
• Source: The First Affiliated Hospital of Guangzhou Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is the study of 64Cu-FAPI-XT117, which is an prospective, single-arm phase I clinical study.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: December 18, 2023
• Est. primary completion date: October 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 1. signed the informed consent
• 2. =18 years old
• 3. confirmed as malignant solid tumor by histopathology or clinical judgment
• 4. Patients will undergo 18F-FDG PET/CT examination

Exclusion Criteria:

• 1. Known allergy to components of the investigational drug or its analogues
• 2. suspected to have a certain disease or condition that is not suitable for the study drug
• 3. Known pregnant or lactating women

Related Conditions & MeSH terms

• Malignant Solid Tumors
• Neoplasms

Intervention

Drug:
• 2.5-3.5mCi 64Cu-FAPI-XT117
64Cu-FAPI-XT117 and 18F-FDG PET/CT were performed for each patient(the interval was more than one day and less than four weeks). PET/CT images were acquired 30min, 60min, 120min after 2.5-3.5mCi 64Cu-FAPI-XT117 injection.
• 3.5-4.5mCi 64Cu-FAPI-XT117
64Cu-FAPI-XT117 and 18F-FDG PET/CT were performed for each patient(the interval was more than one day and less than four weeks). PET/CT images were acquired 30min, 60min, 120min after 3.5-4.5mCi 64Cu-FAPI-XT117 injection.
• 4.5-5.5mCi 64Cu-FAPI-XT117
64Cu-FAPI-XT117 and 18F-FDG PET/CT were performed for each patient(the interval was more than one day and less than four weeks). PET/CT images were acquired 30min, 60min, 120min after 4.5-5.5mCi 64Cu-FAPI-XT117 injection.

Locations

Country	Name	City	State
China	The First Affiliated Hospital of Guangzhou Medical University	Guangzhou

Sponsors (2)

Lead Sponsor	Collaborator
The First Affiliated Hospital of Guangzhou Medical University	Sinotau Pharmaceutical Group

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Uptake of the 64Cu-FAPI-XT and optimal scanning specifications for future studies		From first dose of imaging study drug through two hours post dose
Other	Determine impact of administered dose of 64Cu-FAPI-XT on image quality		From first dose of imaging study drug through two hours post dose
Primary	Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]	Evaluation of Adverse Events (AE) Using CTCAE	7 days following injection]
Secondary	The diagnostic efficacy of 64Cu-FAPI-XT injection in PET/CT imaging of patients with malignant solid tumor	Accuracy (AC), sensitivity (SE), specificity (SP), positive predictive value (PPV)	2 months following injection
Secondary	Change in 'treatment strategy questionnaire'	Referring physicians were asked to complete and return 2 questionnaires. The first assessed the existing treatment plan for the patient without the information from 64Cu-FAPI-XT PET. The second inquired about intended management after receipt of the written clinical report and the 64Cu-FAPI-XT PET images.	2 months following injection