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

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

Status

UNKNOWN

Phases

Early Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05875753

Enrollment

Registered

2023-05-25

Start date

2022-06-01

Completion date

2024-06-01

Last updated

2023-05-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pancreatic Cancer

Keywords

68Ga-FAPI-FS, PET/CT

Brief summary

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

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.

Interventions

DIAGNOSTIC_TEST68Ga-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.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

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

Secondary

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

Countries

China

Contacts

Primary ContactLi Huo, MD

huoli@pumch.cn18612672038

Backup ContactWenjia Zhu, MD

zhuwenjia_pumc@163.com18614080164

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026