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

December 19, 2023 updated by: Xinlu Wang, The First Affiliated Hospital of Guangzhou Medical University
This is the study of 64Cu-FAPI-XT117, which is an prospective, single-arm phase I clinical study.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

15

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
      • Guangzhou, China
        • The First Affiliated Hospital of Guangzhou Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 64Cu-FAPI-XT117 PET/CT
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.
Drug: 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.
Drug: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Time Frame: 7 days following injection]
Evaluation of Adverse Events (AE) Using CTCAE
7 days following injection]

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The diagnostic efficacy of 64Cu-FAPI-XT injection in PET/CT imaging of patients with malignant solid tumor
Time Frame: 2 months following injection
Accuracy (AC), sensitivity (SE), specificity (SP), positive predictive value (PPV)
2 months following injection
Change in 'treatment strategy questionnaire'
Time Frame: 2 months following injection
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

Other Outcome Measures

Outcome Measure
Time Frame
Uptake of the 64Cu-FAPI-XT and optimal scanning specifications for future studies
Time Frame: From first dose of imaging study drug through two hours post dose
From first dose of imaging study drug through two hours post dose
Determine impact of administered dose of 64Cu-FAPI-XT on image quality
Time Frame: From first dose of imaging study drug through two hours post dose
From first dose of imaging study drug through two hours post dose

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The First Affiliated Hospital of Guangzhou Medical University

Collaborators

Sinotau Pharmaceutical Group

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 26, 2023

Primary Completion (Actual)

October 31, 2023

Study Completion (Actual)

December 18, 2023

Study Registration Dates

First Submitted

June 26, 2023

First Submitted That Met QC Criteria

June 26, 2023

First Posted (Actual)

July 5, 2023

Study Record Updates

Last Update Posted (Actual)

December 26, 2023

Last Update Submitted That Met QC Criteria

December 19, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • XT-XTR016-1-02

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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