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Completed

NCT Number: NCT05930457

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

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

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Key information

Conditions

Malignant Solid Tumors

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

The First Affiliated Hospital of Guangzhou Medical University

Guangzhou, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

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.

Primary outcomes

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

    Time frame: 7 days following injection]

    Evaluation of Adverse Events (AE) Using CTCAE

Secondary outcomes

  1. 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. 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.

Other outcomes

  1. 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

  2. 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

Sponsors and collaborators

Lead sponsor

The First Affiliated Hospital of Guangzhou Medical University

Other

Collaborators

  • Sinotau Pharmaceutical Group

Registry information

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Jul 5, 2023
Registry last updated
Dec 26, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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