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

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ClinicalTrials.gov Identifier: NCT02683824
Recruitment Status : Recruiting
First Posted : February 17, 2016
Last Update Posted : September 7, 2018
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Sanjiv Sam Gambhir, Stanford University

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.

Condition or disease Intervention/treatment Phase
Healthy Subject Pancreatic Carcinoma Diagnostic Test: Computed Tomography Other: Laboratory Biomarker Analysis Diagnostic Test: PET/MRI scan Drug: [18F]FP-R01-MG-F2 Early Phase 1

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  (Clinical Trial)
Estimated Enrollment : 25 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Detection of Integrin Alpha-v-Beta 6 in Pancreatic Cancer With [18F]-R01-MG-F2: a First in Human Study
Actual Study Start Date : January 12, 2016
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine


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.
Diagnostic Test: Computed Tomography
Undergo CT scan
Other Names:
  • CAT
  • CAT Scan
  • Computerized Axial Tomography
  • Computerized Tomography
  • CT
  • CT SCAN
  • tomography

Other: Laboratory Biomarker Analysis
Correlative studies

Diagnostic Test: PET/MRI scan
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

Drug: [18F]FP-R01-MG-F2
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.
Diagnostic Test: Computed Tomography
Undergo CT scan
Other Names:
  • CAT
  • CAT Scan
  • Computerized Axial Tomography
  • Computerized Tomography
  • CT
  • CT SCAN
  • tomography

Other: Laboratory Biomarker Analysis
Correlative studies

Diagnostic Test: PET/MRI scan
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

Drug: [18F]FP-R01-MG-F2
radioactive tracer




Primary Outcome Measures :
  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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02683824


Contacts
Contact: Jordan Cisneros 650-725-6409 jdcis@stanford.edu

Locations
United States, California
Stanford University, School of Medicine Recruiting
Palo Alto, California, United States, 94304
Contact: CCTO    650-498-7061    ccto-office@stanford.edu   
Principal Investigator: Sanjiv Gambhir         
Principal Investigator: Andrei Iagaru         
Sponsors and Collaborators
Sanjiv Sam Gambhir
National Cancer Institute (NCI)
Investigators
Principal Investigator: Sanjiv Gambhir Stanford Cancer Institute

Responsible Party: Sanjiv Sam Gambhir, Virginia and D.K. Ludwig Professor for Clinical Investigation in Cancer Research and Professor, by courtesy, of Bioengineering and of Materials Science and Engineering, Stanford University
ClinicalTrials.gov Identifier: NCT02683824     History of Changes
Other Study ID Numbers: PANC0020
NCI-2015-01887 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
4593
PANC0020 ( Other Identifier: Stanford Cancer Institute )
P30CA124435 ( U.S. NIH Grant/Contract )
First Posted: February 17, 2016    Key Record Dates
Last Update Posted: September 7, 2018
Last Verified: September 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases