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Completed

NCT Number: NCT02683824

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

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.

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Key information

Conditions

Healthy Subject Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Neoplasms Neoplasms by Site Pancreatic Carcinoma Pancreatic Diseases Pancreatic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Stanford University, School of Medicine

Palo Alto, California, 94304, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Computed Tomography

Diagnostic Test

Undergo CT scan

Other names: CAT, CAT Scan, Computerized Axial Tomography, Computerized Tomography, CT, CT SCAN, tomography

laboratory biomarker analysis

Other

Correlative studies

PET/MRI scan

Diagnostic Test

Undergo PET/MRI scan

Other names: Medical Imaging, Positron Emission Tomography, PET, PET SCAN, Positron Emission Tomography, Positron Emission Tomography Scan, Positron-Emission Tomography, magnetic resonance imaging

[18F]FP-R01-MG-F2

Drug

radioactive tracer

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

Detection of Integrin Alpha-v-Beta 6 in Pancreatic Cancer With [18F]-R01-MG-F2: a First in Human Study

Important dates

Study start
2016
Primary completion
2021
Study completion
2022
First posted
Feb 17, 2016
Registry last updated
Sep 21, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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