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Completed

NCT Number: NCT05814835

First in Human Study of 68Ga/64Cu-FAPI-XT117 PET/CT in Patients With Malignant Solid Tumors

This is the first-in-human study of 68Ga/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 Medical Center, Chinese PLA General Hospital

Beijing, 100023, China

About this study

20 patients with confirmed diagnosis of malignant solid tumor by histopathology or clinical judgment and required routine 18F-FDG PET/CT imaging were recruited. 68Ga/64Cu-FAPI-XT117 and 18F-FDG PET/CT were performed for each patient in any order(the interval was more than one day and less than four weeks). They were assigned to three 68Ga/64Cu-FAPI-XT117 dose groups, including 3±10% mCi、5±10% mCi and 7 ±10% mCi. PET/CT images were acquired 30min, 60min, 120min after injection. The primary end point was safety, secondary endpoints were accuracy (AC), sensitivity (SE), specificity (SP), positive predictive value (PPV), and change in management. Exploring end point was image quality, including qualitative and quantitative evaluation.

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

2-4 mCi 68Ga/64Cu-FAPI-XT117

Drug

68Ga/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 2-4 mCi 68Ga/64Cu-FAPI-XT117 injection.

4-6 mCi 68Ga/64Cu-FAPI-XT117

Drug

68Ga/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 4-6 mCi 68Ga/64Cu-FAPI-XT117 injection.

6-8 mCi 68Ga/64Cu-FAPI-XT117

Drug

68Ga/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 6-8 mCi 68Ga/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 68Ga/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 68Ga/64Cu-FAPI-XT PET. The second inquired about intended management after receipt of the written clinical report and the 68Ga/64Cu-FAPI-XT PET images.

Sponsors and collaborators

Lead sponsor

Chinese PLA General Hospital

Other

Collaborators

  • Sinotau Pharmaceutical Group

Registry information

Official study title

First in Human Study of 68Ga/64Cu-FAPI-XT117 PET/CT in Patients With Malignant

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Apr 18, 2023
Registry last updated
Dec 20, 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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