Integrin Alpha-v-Beta and [18F]-R01-MG-F2 PET/CT in Measuring Response in Patients With Pancreatic Cancer and Healthy Volunteers

NCT02683824 | Completed Early Phase 1 DMC FDA Drug

• 5 other identifiers: IRB-34376NCI-2015-018874593PANC0020P30CA124435
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Subject; Pancreatic Carcinoma

Outcome Measures

Primary Outcomes (4)

• Biodistribution of [18F]FP-R01-MG-F2 (%ID/g)

  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)

  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)

  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)

  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

Study Arms (2)

pancreatic cancer patients

EXPERIMENTAL

Patients receive \[18F\]FP-R01-MG-F2 IV and undergo PET/CT or PET/MRI scan immediately after and at 60 and 120 minutes.

Diagnostic Test: Computed Tomography; Other: Laboratory Biomarker Analysis; Diagnostic Test: PET/MRI scan; Drug: [18F]FP-R01-MG-F2

healthy patients

EXPERIMENTAL

Patients receive \[18F\]FP-R01-MG-F2 IV and undergo PET/CT or PET/MRI scan immediately after and at 60 and 120 minutes.

Diagnostic Test: Computed Tomography; Other: Laboratory Biomarker Analysis; Diagnostic Test: PET/MRI scan; Drug: [18F]FP-R01-MG-F2

Interventions

Computed Tomography DIAGNOSTIC_TEST

Undergo CT scan

Also known as: CAT, CAT Scan, Computerized Axial Tomography, Computerized Tomography, CT, CT SCAN, tomography

healthy patients; pancreatic cancer patients

Laboratory Biomarker Analysis OTHER

Correlative studies

healthy patients; pancreatic cancer patients

PET/MRI scan DIAGNOSTIC_TEST

Undergo PET/MRI scan

Also known as: Medical Imaging, Positron Emission Tomography, PET, PET SCAN, Positron Emission Tomography, Positron Emission Tomography Scan, Positron-Emission Tomography, magnetic resonance imaging

healthy patients; pancreatic cancer patients

[18F]FP-R01-MG-F2 DRUG

radioactive tracer

healthy patients; pancreatic cancer patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Stanford University: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Stanford University, School of Medicine

Palo Alto, California, 94304, United States

Location

Related Publications (1)

• 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.

  PMID: 34729628 DERIVED

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Tomography, X-Ray Computed; Tomography; Positron-Emission Tomography; Magnetic Resonance Imaging

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Image Interpretation, Computer-Assisted; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Radiographic Image Enhancement; Image Enhancement; Photography; Radiography; Tomography, X-Ray; Tomography, Emission-Computed; Radionuclide Imaging; Diagnostic Techniques, Radioisotope

Study Officials

• Andrei Iagaru

  Stanford Cancer Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 21, 2016
• First Posted: February 17, 2016
• Study Start: January 12, 2016
• Primary Completion: September 27, 2021
• Study Completion: December 1, 2022
• Last Updated: September 21, 2023

Record last verified: 2023-09

Locations

US (1)