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

Primary Purpose

Pancreatic Cancer

Status
Recruiting
Phase
Early Phase 1
Locations
China
Study Type
Interventional
Intervention
68Ga-FAPI-FS PET/CT
Sponsored by
Peking Union Medical College Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Pancreatic Cancer focused on measuring 68Ga-FAPI-FS, PET/CT

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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. Exclusion Criteria: Pregnancy or breastfeeding. Severe claustrophobia.

Sites / Locations

  • Peking Union Medical College HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

68Ga-FAPI-FS PET/CT

Arm Description

Each patient will receive one dose of 68Ga-FAPI-FS by intravenous route. Dedicated whole-body PET/CT imaging will be performed.

Outcomes

Primary Outcome Measures

Adverse events after injection of 68Ga-FAPI-FS
Adverse events will be recorded according to CTCEA v4.03

Secondary Outcome Measures

SUVmax of liver on 68Ga-FAPI-FS
The liver uptake will be measured using SUVmax with a 40% threshold.
SUVmax of normal pancreas on 68Ga-FAPI-FS
The normal pancreas uptake will be measured using SUVmax with a 40% threshold.
SUVmax of blood pool on 68Ga-FAPI-FS
The blood pool uptake will be measured using SUVmax with a 40% threshold.
SUVmax of lung on 68Ga-FAPI-FS
The lung uptake will be measured using SUVmax with a 40% threshold.
SUVmax of brain on 68Ga-FAPI-FS
The brain uptake will be measured using SUVmax with a 40% threshold.
SUVmax of muscle on 68Ga-FAPI-FS
The muscle will be measured using SUVmax with a 40% threshold.
SUVmax of tumor lesions on 68Ga-FAPI-FS
The tumor lesions will be measured using SUVmax with a 40% threshold.

Full Information

First Posted
May 16, 2023
Last Updated
May 16, 2023
Sponsor
Peking Union Medical College Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05875753
Brief Title
68Ga-FAPI-FS PET/CT and PET/MR in Pancreatic Cancer
Official Title
Preliminary Study of 68Ga-FAPI-FS PET/CT in Patients With Pancreatic Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 1, 2022 (Actual)
Primary Completion Date
June 1, 2024 (Anticipated)
Study Completion Date
June 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Peking Union Medical College Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Cancer
Keywords
68Ga-FAPI-FS, PET/CT

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
68Ga-FAPI-FS PET/CT
Arm Type
Experimental
Arm Description
Each patient will receive one dose of 68Ga-FAPI-FS by intravenous route. Dedicated whole-body PET/CT imaging will be performed.
Intervention Type
Diagnostic Test
Intervention Name(s)
68Ga-FAPI-FS PET/CT
Intervention Description
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.
Primary Outcome Measure Information:
Title
Adverse events after injection of 68Ga-FAPI-FS
Description
Adverse events will be recorded according to CTCEA v4.03
Time Frame
From tracer injection to 3 hour post-injection
Secondary Outcome Measure Information:
Title
SUVmax of liver on 68Ga-FAPI-FS
Description
The liver uptake will be measured using SUVmax with a 40% threshold.
Time Frame
From study completion to 1 month after completion
Title
SUVmax of normal pancreas on 68Ga-FAPI-FS
Description
The normal pancreas uptake will be measured using SUVmax with a 40% threshold.
Time Frame
From study completion to 1 month after completion
Title
SUVmax of blood pool on 68Ga-FAPI-FS
Description
The blood pool uptake will be measured using SUVmax with a 40% threshold.
Time Frame
From study completion to 1 month after completion
Title
SUVmax of lung on 68Ga-FAPI-FS
Description
The lung uptake will be measured using SUVmax with a 40% threshold.
Time Frame
From study completion to 1 month after completion
Title
SUVmax of brain on 68Ga-FAPI-FS
Description
The brain uptake will be measured using SUVmax with a 40% threshold.
Time Frame
From study completion to 1 month after completion
Title
SUVmax of muscle on 68Ga-FAPI-FS
Description
The muscle will be measured using SUVmax with a 40% threshold.
Time Frame
From study completion to 1 month after completion
Title
SUVmax of tumor lesions on 68Ga-FAPI-FS
Description
The tumor lesions will be measured using SUVmax with a 40% threshold.
Time Frame
From study completion to 1 month after completion

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: Pregnancy or breastfeeding. Severe claustrophobia.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Li Huo, MD
Phone
18612672038
Email
huoli@pumch.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Wenjia Zhu, MD
Phone
18614080164
Email
zhuwenjia_pumc@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Li Huo, MD
Organizational Affiliation
Peking Uion Medical College Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Peking Union Medical College Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100730
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wenjia Zhu, MD
Phone
18614080164
Email
zhuwenjia_pumc@163.com
First Name & Middle Initial & Last Name & Degree
Li Huo, MD
Phone
18612672038
Email
huoli@pumch.cn

12. IPD Sharing Statement

Plan to Share IPD
No

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

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