Clinical trial NCT02683824: Integrin Alpha-v-Beta and [18F]-R01-MG-F2 PET/CT in Measuring Response in Patients With Pancreatic Cancer and Healthy Volunteers
Official title: Detection of Integrin Alpha-v-Beta 6 in Pancreatic Cancer With [18F]-R01-MG-F2: a First in Human Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Healthy Subject
Pancreatic Carcinoma
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2016-02-17
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: 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.

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.

Eligibility criteria: Inclusion Criteria:

Healthy volunteers:

1. Must be 18 years of age or older.
2. 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.
3. Must understand and voluntarily have signed an Informed Consent after its contents have been fully explained.
4. 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:

1. Participant must be 18 years or older at the time of radiotracer administration
2. Provides written informed consent
3. 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:

1. Participant is less than 18 year-old
2. Pregnant or breast feeding women.
3. Patients who are not likely to comply with the protocol requirements.

Pancreatic cancer subjects:

1. Participant is pregnant or breast-feeding
2. Participant is not able to comply with the study procedures
3. Participant has serious uncontrolled concurrent medical illness that would limit compliance with study requirements
4. Metallic implants (contraindicated for MRI)
5. History of renal insufficiency (only for MRI contrast administration)

Primary outcomes:
measure: Biodistribution of [18F]FP-R01-MG-F2 (%ID/g)
timeFrame: Up to 3 hours after tracer injection
measure: Biodistribution of [18F]FP-R01-MG-F2 (SUV)
timeFrame: Up to 3 hours after tracer injection
measure: Dosimetry of [18F]FP-R01-MG-F2 (rem/mCi)
timeFrame: Up to 3 hours after tracer injection
measure: Dosimetry of [18F]FP-R01-MG-F2 (mSv/MBq)
timeFrame: Up to 3 hours after tracer injection
Secondary outcomes:
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Stanford University, School of Medicine
state: California
Study officials:
affiliation: Stanford Cancer Institute
name: Andrei Iagaru
role: PRINCIPAL_INVESTIGATOR
References:
citation: Nakamoto R, Ferri V, Duan H, Hatami N, Goel M, Rosenberg J, Kimura R, Wardak M, Haywood T, Kellow R, Shen B, Park W, Iagaru A, Gambhir SS. Pilot-phase PET/CT study targeting integrin alphavbeta6 in pancreatic cancer patients using the cystine-knot peptide-based 18F-FP-R01-MG-F2. Eur J Nucl Med Mol Imaging. 2022 Dec;50(1):184-193. doi: 10.1007/s00259-021-05595-7. Epub 2021 Nov 3.