68Ga-FAPI-FS PET/CT and PET/MR in Pancreatic Cancer

May 16, 2023 updated by: Peking Union Medical College Hospital

Preliminary Study of 68Ga-FAPI-FS PET/CT in Patients With Pancreatic Cancer

This is a preliminary study of 68Ga-FAPI-FS PET/CT or PET/MR in patients with confirmed or suspicious pancreatic cancer. The goal is to determine the safety, biodistribution, and tumor uptake of 68Ga-FAPI-FS.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This is a preliminary phase 0 study in patients with confirmed or suspicious pancreatic cancer. Each patient will receive one dose of 68Ga-FAPI-FS by intravenous route. Dedicated whole-body PET/CT imaging will be performed. A comparative 18F-FDG PET/CT will also be performed within a week.

Study Type

Interventional

Enrollment (Estimated)

50

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 Contact Backup

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100730
        • Recruiting
        • Peking Union Medical College Hospital
        • Contact:
        • 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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Pancreatic cancer confirmed by histopathological results or pancreatic lesions with typical radiological appearance.
  2. Expected survival of at least 3 months
  3. ECOG ≤ 2
  4. Written informed consent provided for participation in the trial
  5. In the opinion of investigator, willing and able to comply with required study procedures.

Exclusion Criteria:

  1. Pregnancy or breastfeeding.
  2. Severe claustrophobia.

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 68Ga-FAPI-FS PET/CT
Each patient will receive one dose of 68Ga-FAPI-FS by intravenous route. Dedicated whole-body PET/CT imaging will be performed.
Diagnostic test: 68Ga-FAPI-FS PET/CT

Participants will be administered a single, intravenous bolus of 68Ga-FAPI-FS. The recommended administered activity of 68Ga-NY104 is 1.8-2.2 MBq per kilogram bodyweight, subject to variation that may be required owing to variable elution efficiencies obtained during the lifetime of the 68Ga / 68Ga generator.

The CT and PET imaging session will begin approximately 45 to 75 minutes after 68Ga-FAPI-FS administration.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse events after injection of 68Ga-FAPI-FS
Time Frame: From tracer injection to 3 hour post-injection
Adverse events will be recorded according to CTCEA v4.03
From tracer injection to 3 hour post-injection

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
SUVmax of liver on 68Ga-FAPI-FS
Time Frame: From study completion to 1 month after completion
The liver uptake will be measured using SUVmax with a 40% threshold.
From study completion to 1 month after completion
SUVmax of normal pancreas on 68Ga-FAPI-FS
Time Frame: From study completion to 1 month after completion
The normal pancreas uptake will be measured using SUVmax with a 40% threshold.
From study completion to 1 month after completion
SUVmax of blood pool on 68Ga-FAPI-FS
Time Frame: From study completion to 1 month after completion
The blood pool uptake will be measured using SUVmax with a 40% threshold.
From study completion to 1 month after completion
SUVmax of lung on 68Ga-FAPI-FS
Time Frame: From study completion to 1 month after completion
The lung uptake will be measured using SUVmax with a 40% threshold.
From study completion to 1 month after completion
SUVmax of brain on 68Ga-FAPI-FS
Time Frame: From study completion to 1 month after completion
The brain uptake will be measured using SUVmax with a 40% threshold.
From study completion to 1 month after completion
SUVmax of muscle on 68Ga-FAPI-FS
Time Frame: From study completion to 1 month after completion
The muscle will be measured using SUVmax with a 40% threshold.
From study completion to 1 month after completion
SUVmax of tumor lesions on 68Ga-FAPI-FS
Time Frame: From study completion to 1 month after completion
The tumor lesions will be measured using SUVmax with a 40% threshold.
From study completion to 1 month after completion

Collaborators and Investigators

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

Sponsor

Peking Union Medical College Hospital

Investigators

  • Principal Investigator: Li Huo, MD, Peking Uion Medical College Hospital

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)

June 1, 2022

Primary Completion (Estimated)

June 1, 2024

Study Completion (Estimated)

June 1, 2024

Study Registration Dates

First Submitted

May 16, 2023

First Submitted That Met QC Criteria

May 16, 2023

First Posted (Actual)

May 25, 2023

Study Record Updates

Last Update Posted (Actual)

May 25, 2023

Last Update Submitted That Met QC Criteria

May 16, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FAPI-FS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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