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

NCT05875753 | Unknown Early Phase 1

• 1 other identifier: FAPI-FS
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Pancreatic Cancer

Keywords

68Ga-FAPI-FS; PET/CT

Outcome Measures

Primary Outcomes (1)

• Adverse events after injection of 68Ga-FAPI-FS

  Adverse events will be recorded according to CTCEA v4.03

  From tracer injection to 3 hour post-injection

Secondary Outcomes (7)

• SUVmax of liver on 68Ga-FAPI-FS

  From study completion to 1 month after completion

• SUVmax of normal pancreas on 68Ga-FAPI-FS

  From study completion to 1 month after completion

• SUVmax of blood pool on 68Ga-FAPI-FS

  From study completion to 1 month after completion

• SUVmax of lung on 68Ga-FAPI-FS

  From study completion to 1 month after completion

• SUVmax of brain on 68Ga-FAPI-FS

  From study completion to 1 month after completion

Study Arms (1)

68Ga-FAPI-FS PET/CT

EXPERIMENTAL

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

Interventions

68Ga-FAPI-FS PET/CT 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.

68Ga-FAPI-FS PET/CT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Pregnancy or breastfeeding.
• Severe claustrophobia.

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead

Study Sites (1)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100730, China

RECRUITING

MeSH Terms

Conditions

Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Study Officials

• Li Huo, MD

  Peking Uion Medical College Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Li Huo, MD

CONTACT

18612672038; huoli@pumch.cn

Wenjia Zhu, MD

CONTACT

18614080164; zhuwenjia_pumc@163.com

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 16, 2023
• First Posted: May 25, 2023
• Study Start: June 1, 2022
• Primary Completion: June 1, 2024
• Study Completion: June 1, 2024
• Last Updated: May 25, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)