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

NCT05930457 | Completed Phase 1

• 1 other identifier: XT-XTR016-1-02
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Malignant Solid Tumors

Outcome Measures

Primary Outcomes (1)

• Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]

  Evaluation of Adverse Events (AE) Using CTCAE

  7 days following injection]

Secondary Outcomes (2)

• The diagnostic efficacy of 64Cu-FAPI-XT injection in PET/CT imaging of patients with malignant solid tumor

  2 months following injection

• Change in 'treatment strategy questionnaire'

  2 months following injection

Other Outcomes (2)

• 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

• Determine impact of administered dose of 64Cu-FAPI-XT on image quality

  From first dose of imaging study drug through two hours post dose

Study Arms (1)

64Cu-FAPI-XT117 PET/CT

EXPERIMENTAL

Drug: 2.5-3.5mCi 64Cu-FAPI-XT117; Drug: 3.5-4.5mCi 64Cu-FAPI-XT117; Drug: 4.5-5.5mCi 64Cu-FAPI-XT117

Interventions

2.5-3.5mCi 64Cu-FAPI-XT117 DRUG

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.

64Cu-FAPI-XT117 PET/CT

3.5-4.5mCi 64Cu-FAPI-XT117 DRUG

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.

64Cu-FAPI-XT117 PET/CT

4.5-5.5mCi 64Cu-FAPI-XT117 DRUG

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.

64Cu-FAPI-XT117 PET/CT

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• The First Affiliated Hospital of Guangzhou Medical University: lead
• Sinotau Pharmaceutical Group: collaborator

Study Sites (1)

The First Affiliated Hospital of Guangzhou Medical University

Guangzhou, China

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: chief of nuclear medicine department

Study Record Dates

• First Submitted: June 26, 2023
• First Posted: July 5, 2023
• Study Start: July 26, 2023
• Primary Completion: October 31, 2023
• Study Completion: December 18, 2023
• Last Updated: December 26, 2023

Record last verified: 2023-12

Locations

CN (1)