Integrin Alpha-v-Beta and [18F]-R01-MG-F2 PET/CT in Measuring Response in Patients With Pancreatic Cancer and Healthy Volunteers
September 20, 2023 updated by: Stanford University
Detection of Integrin Alpha-v-Beta 6 in Pancreatic Cancer With [18F]-R01-MG-F2: a First in Human Study
This pilot clinical trial studies the use of integrin alpha-v-beta [18F]-R01-MG-F2 Positron Emission Tomography/Computed Tomography (PET/CT) and Positron Emission Tomography-Magnetic Resonance Imaging in (PET/MRI) in measuring response in patients with pancreatic cancer and healthy volunteers.
Integrins, such as integrin alpha-v-beta-6 (avb6), are a family of membrane receptors that are overexpressed on the cell surface of pancreatic cancers.
[18F]-R01-MG-F2 targets avb6, which may improve early detection of and better stratify treatment options for patients with pancreatic cancer.
Study Overview
Status
Completed
Conditions
Detailed Description
PRIMARY OBJECTIVES:
I. Evaluate the biodistribution and safety of [18F]FP-R01-MG-F2 in healthy volunteers.
II. Evaluate the feasibility of [18F]FP-R01-MG-F2 PET/CT scanning in patients with pancreatic cancer.
OUTLINE:
Patients receive [18F]FP-R01-MG-F2 intravenously (IV) and undergo PET/CT or PET/MR scan immediately after and at 60 and 120 minutes. Patients will be followed up at 24-48 hours.
Study Type
Interventional
Enrollment (Actual)
21
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 Locations
-
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California
-
Palo Alto, California, United States, 94304
- Stanford University, School of Medicine
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-
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
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
Healthy volunteers:
- Must be 18 years of age or older.
- Must have no known medical problems and have had a full medical exam within 6 months of the study. If healthy volunteers have not had a full medical exam within 6 months of the study, one of the nuclear medicine physicians will conduct the medical exam prior to any study procedures.
- Must understand and voluntarily have signed an Informed Consent after its contents have been fully explained.
- Women of child bearing potential (as defined as women who are not post menopausal for 12 months or who have had no previous surgical sterilization) and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation and for 30 days after the last dose.
Pancreatic cancer subjects:
- Participant must be 18 years or older at the time of radiotracer administration
- Provides written informed consent
- Suspected or established diagnosis of pancreatic cancer based on any radiographic scan or pathology and who is scheduled for surgery OR Biopsy proven diagnosis of pancreatic cancer who is no longer a surgical candidate
Exclusion Criteria:
Healthy volunteers:
- Participant is less than 18 year-old
- Pregnant or breast feeding women.
- Patients who are not likely to comply with the protocol requirements.
Pancreatic cancer subjects:
- Participant is pregnant or breast-feeding
- Participant is not able to comply with the study procedures
- Participant has serious uncontrolled concurrent medical illness that would limit compliance with study requirements
- Metallic implants (contraindicated for MRI)
- History of renal insufficiency (only for MRI contrast administration)
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: Basic Science
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: pancreatic cancer patients
Patients receive [18F]FP-R01-MG-F2 IV and undergo PET/CT or PET/MRI scan immediately after and at 60 and 120 minutes.
|
Correlative studies
Undergo CT scan
Other Names:
Undergo PET/MRI scan
Other Names:
radioactive tracer
|
|
Experimental: healthy patients
Patients receive [18F]FP-R01-MG-F2 IV and undergo PET/CT or PET/MRI scan immediately after and at 60 and 120 minutes.
|
Correlative studies
Undergo CT scan
Other Names:
Undergo PET/MRI scan
Other Names:
radioactive tracer
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Biodistribution of [18F]FP-R01-MG-F2 (%ID/g)
Time Frame: Up to 3 hours after tracer injection
|
From the Region-of-Interest (ROI) image analysis, the biodistribution data will be reported in percent injected dose per gram of tissue (%ID/g).
ROI analysis will be performed on normal brain, thyroid, lungs, mediastinum, liver, spleen, intestines, kidneys, urinary bladder and gluteal muscle.
|
Up to 3 hours after tracer injection
|
|
Biodistribution of [18F]FP-R01-MG-F2 (SUV)
Time Frame: Up to 3 hours after tracer injection
|
From the Region-of-Interest (ROI) image analysis, the biodistribution data will be reported in Standardized Uptake Values (SUV).
ROI analysis will be performed on normal brain, thyroid, lungs, mediastinum, liver, spleen, intestines, kidneys, urinary bladder and gluteal muscle.
|
Up to 3 hours after tracer injection
|
|
Dosimetry of [18F]FP-R01-MG-F2 (rem/mCi)
Time Frame: Up to 3 hours after tracer injection
|
Using the biodistribution data (uptake in %ID/g or SUV), the tracer's complete dosimetry across all organs, tissues or cells will be determined using the OLINDA software.
These data will be reported in rem/mCi.
|
Up to 3 hours after tracer injection
|
|
Dosimetry of [18F]FP-R01-MG-F2 (mSv/MBq)
Time Frame: Up to 3 hours after tracer injection
|
Using the biodistribution data (uptake in %ID/g or SUV), the tracer's complete dosimetry across all organs, tissues or cells will be determined using the OLINDA software.
These data will be reported in mSv/MBq.
|
Up to 3 hours after tracer injection
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Andrei Iagaru, Stanford Cancer Institute
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
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)
January 12, 2016
Primary Completion (Actual)
September 27, 2021
Study Completion (Actual)
December 1, 2022
Study Registration Dates
First Submitted
January 21, 2016
First Submitted That Met QC Criteria
February 10, 2016
First Posted (Estimated)
February 17, 2016
Study Record Updates
Last Update Posted (Actual)
September 21, 2023
Last Update Submitted That Met QC Criteria
September 20, 2023
Last Verified
September 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB-34376
- 4593 (Other Identifier: superceded IRB number)
- P30CA124435 (U.S. NIH Grant/Contract)
- NCI-2015-01887 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
- PANC0020 (Other Identifier: OnCore)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
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