Tracer Targeting FAP PET Imaging in Patients

January 19, 2023 updated by: Chunjing Yu, Affiliated Hospital of Jiangnan University
This is a single arm study to evaluate the safety and biodistribution of tracer targeting FAP PET Imaging in patients

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Early 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
      • Wuxi, China, 214000
        • Recruiting
        • Affiliated Hospital of Jiangnan University
        • Contact:

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

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Patients voluntarily signed informed consent;
  2. Age 18-75, male or female;
  3. Patients diagnosed with cancer confirmed by histopathology or cytology;
  4. At least one measurable solid lesion has been examined according RECIST1.1 standard;
  5. ECOG score 0~2.

Exclusion Criteria:

  1. Recovery from major trauma (including surgery) within 4 weeks prior to study treatment;
  2. Patients with systemic or locally severe infections, or other serious coexisting diseases;
  3. Patients with abnormal immune function or who have recently used immunosuppressive or potentiating agents including various vaccines;
  4. Patients with autoimmune diseases, including rheumatoid arthritis;
  5. Inadequate control of arrhythmias, including atrial fibrillation;
  6. Uncontrolled hypertension;
  7. Patients with allergies or allergies to any component of the imaging agent or antibody;
  8. Patients who cannot undergo PET/CT imaging scan;
  9. Syphilis, HBV, HCV, or HIV positive subjects;
  10. Male and female subjects of reproductive age cannot take effective contraceptive measures;
  11. Pregnant or lactating women;
  12. Patients with a history of mental illness or related conditions;
  13. Other subjects considered unsuitable by researchers.

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: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 18F-FAPI
Drug: 18F-FAPI
Patients will receive a tracer dose of 18F (8-10mCi) labelled FAPI
Experimental: 68Ga-FAPI
Drug: 68Ga-FAPI
Patients will receive a tracer dose of 68Ga (2-5mCi) labelled FAPI

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluation of tissue distribution of 18F-FAPI
Time Frame: 1 day
Biodistribution of 18F-FAPI evaluated by radioactive uptake values (standardized uptake values, SUVs) in various organs during repeated 18F-PET scans will be reported.
1 day
Evaluation of tissue distribution of 68Ga-FAPI
Time Frame: 1 day
Biodistribution of 68Ga-FAPI evaluated by radioactive uptake values (standardized uptake values, SUVs) in various organs during repeated 68Ga-PET scans will be reported.
1 day

Collaborators and Investigators

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

Sponsor

Affiliated Hospital of Jiangnan University

Investigators

  • Principal Investigator: Chunjing Yu, Affiliated Hospital of Jiangnan University

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)

November 2, 2022

Primary Completion (Anticipated)

November 1, 2023

Study Completion (Anticipated)

November 1, 2023

Study Registration Dates

First Submitted

January 11, 2023

First Submitted That Met QC Criteria

January 19, 2023

First Posted (Actual)

January 20, 2023

Study Record Updates

Last Update Posted (Actual)

January 20, 2023

Last Update Submitted That Met QC Criteria

January 19, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • LS2020024

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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