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

NCT ID: NCT05875753

Last Updated: 2023-05-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

EARLY_PHASE1

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-06-01

Study Completion Date

2024-06-01

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Pancreatic Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

68Ga-FAPI-FS PET/CT

Intervention Type DIAGNOSTIC_TEST

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.

Interventions

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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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Peking Union Medical College Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Li Huo, MD

Role: PRINCIPAL_INVESTIGATOR

Peking Uion Medical College Hospital

Locations

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Peking Union Medical College Hospital

Beijing, Beijing Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Li Huo, MD

Role: CONTACT

18612672038

Wenjia Zhu, MD

Role: CONTACT

18614080164

Facility Contacts

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Wenjia Zhu, MD

Role: primary

18614080164

Li Huo, MD

Role: backup

18612672038

Other Identifiers

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FAPI-FS

Identifier Type: -

Identifier Source: org_study_id

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