Healthy Subject, Pancreatic Carcinoma
Conditions
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.
Interventions
DIAGNOSTIC_TESTComputed Tomography
Undergo CT scan
OTHERLaboratory Biomarker Analysis
Correlative studies
DIAGNOSTIC_TESTPET/MRI scan
Undergo PET/MRI scan
radioactive tracer
Sponsors
National Cancer Institute (NCI)
Stanford University
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Biodistribution of [18F]FP-R01-MG-F2 (%ID/g) | 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. |
| Biodistribution of [18F]FP-R01-MG-F2 (SUV) | 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. |
| Dosimetry of [18F]FP-R01-MG-F2 (rem/mCi) | 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. |
| Dosimetry of [18F]FP-R01-MG-F2 (mSv/MBq) | 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. |
Countries
United States
Outcome results
None listed