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Tracer Targeting FAP PET Imaging in Patients

Sponsor
Affiliated Hospital of Jiangnan University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05691894
Collaborator
(none)
20
Enrollment
1
Location
2
Arms
12
Anticipated Duration (Months)
1.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This is a single arm study to evaluate the safety and biodistribution of tracer targeting FAP PET Imaging in patients

Condition or Disease Intervention/Treatment Phase
Early Phase 1

Study Design

Study Type:
Interventional
Anticipated Enrollment :
20 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
Tracer Targeting FAP PET Imaging in Patients
Actual Study Start Date :
Nov 2, 2022
Anticipated Primary Completion Date :
Nov 1, 2023
Anticipated Study Completion Date :
Nov 1, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Evaluation of tissue distribution of 18F-FAPI [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.

  2. Evaluation of tissue distribution of 68Ga-FAPI [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Affiliated Hospital of Jiangnan University Wuxi China 214000

Sponsors and Collaborators

  • Affiliated Hospital of Jiangnan University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Chunjing Yu, Director, Affiliated Hospital of Jiangnan University
ClinicalTrials.gov Identifier:
NCT05691894
Other Study ID Numbers:
  • LS2020024
First Posted:
Jan 20, 2023
Last Update Posted:
Jan 20, 2023
Last Verified:
Jan 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Jan 20, 2023