AzTrials
AzTrials

Healthy SubjectEarly Phase 1NCT02683824

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

A Early Phase 1 study testing Computed Tomography, Laboratory Biomarker Analysis and PET/MRI scan in people with Healthy Subject and Pancreatic Carcinoma, run by Stanford University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Healthy Subject, Pancreatic Carcinoma
What is being tested?
Computed Tomography, Laboratory Biomarker Analysis and PET/MRI scan
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
21 participants
Where
1 siteUnited States
Study dates
12 Jan 2016to 1 Dec 2022
Phase
Early Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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:
Show all 9Show fewer
  • 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

Who cannot join

  • 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
Show all 10Show fewer
  • 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)

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Stanford University, School of Medicine

    Palo Alto, California, 94304

Other trials in United States

About this study

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

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.

Read the detailed description

PRIMARY OBJECTIVES:

  1. 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.

Being tested
Computed Tomography, Laboratory Biomarker Analysis, PET/MRI scan, [18F]FP-R01-MG-F2
Medical subject headings
Pancreatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Computed TomographyDiagnostic test

    Also called CAT, CAT Scan, Computerized Axial Tomography, Computerized Tomography

    Undergo CT scan

  • Laboratory Biomarker AnalysisOther

    Correlative studies

  • PET/MRI scanDiagnostic test

    Also called Medical Imaging, Positron Emission Tomography, PET, PET SCAN, Positron Emission Tomography

    Undergo PET/MRI scan

  • [18F]FP-R01-MG-F2Drug

    radioactive tracer

Study groups in NCT02683824
Study groupRoleWhat they receive
pancreatic cancer patientsExperimentalPatients receive [18F]FP-R01-MG-F2 IV and undergo PET/CT or PET/MRI scan immediately after and at 60 and 120 minutes.
Receives: Diagnostic Test: Computed Tomography; Other: Laboratory Biomarker Analysis; Diagnostic Test: PET/MRI scan; Drug: [18F]FP-R01-MG-F2
healthy patientsExperimentalPatients receive [18F]FP-R01-MG-F2 IV and undergo PET/CT or PET/MRI scan immediately after and at 60 and 120 minutes.
Receives: Diagnostic Test: Computed Tomography; Other: Laboratory Biomarker Analysis; Diagnostic Test: PET/MRI scan; Drug: [18F]FP-R01-MG-F2

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Up to 3 hours after tracer injection

  2. 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.

    Measured: Up to 3 hours after tracer injection

  3. 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.

    Measured: Up to 3 hours after tracer injection

  4. 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.

    Measured: Up to 3 hours after tracer injection

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Feb 2016 (estimated)
  2. Study start12 Jan 2016
  3. Primary completion27 Sep 2021
  4. Study completion1 Dec 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Early Phase 1
Primary purpose
Basic science
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
21 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02683824
Sponsor's protocol ID
IRB-34376
Other IDs
NCI-2015-01887, 4593, PANC0020, P30CA124435
Status last verified
Sep 2023
First submitted
21 Jan 2016
Last updated
21 Sep 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • 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.

    PubMed 34729628

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing Computed Tomography, Laboratory Biomarker Analysis and PET/MRI scan in people with Healthy Subject and Pancreatic Carcinoma, run by Stanford University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Biodistribution of [18F]FP-R01-MG-F2 (%ID/g) (time frame: Up to 3 hours after tracer injection). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02683824, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2023.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in