18F-FSPG PET/CT for Cancer Patients on Therapy

December 11, 2018 updated by: Andrei Iagaru

An Exploratory Study of the Role of 18F-FSPG PET/CT Imaging for Cancer Patients Receiving Therapy

The goal of this phase 2 study trial is to evaluate the utility of the radiolabel 18F-FSPG used before and after treatment to diagnose, predict, and evaluate response to therapy in patients with a wide variety of metastatic cancers.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

OUTLINE:

Patients are evaluated with a PET/CT scan using the radiolabel 18F-FSPG [18F-(S)-4-(3-fluoropropyl)-L-glutamic acid] or 18F-FDG ([18F]-fluorodeoxyglucose), before and after therapeutic treatment.

PRIMARY OBJECTIVE:

Uptake of the radiolabel 18F-FSPG in patients with biopsy-proven cancer will be evaluated and compared to the uptake of 18F-FDG, before and after therapy (non-specified) in the same group of patients.

SECONDARY OBJECTIVES:

  • Compare the agreement of the clinical assessment for cancer status between 18F-FSPG and 18F-FDG.
  • Safety and tolerability of 18F-FSPG and 18F-FDG.

Study Type

Interventional

Enrollment (Actual)

7

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Stanford, California, United States, 94304
        • Stanford University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Written informed consent
  • Able to complete a PET/CT scan without the use of sedation

  • Females:

    • Of childbearing potential must:

      • Not be nursing
      • Have a negative serum pregnancy test documented within 48 hours prior to administration of 18F FSPG PET/CT

    • Not of childbearing potential must be:

      • Physiologically postmenopausal (cessation of menses for more than 1 year)
      • Surgically sterile (has had a documented bilateral oophorectomy and/or documented hysterectomy)
  • Histologically confirmed cancer that is advanced; metastatic; or otherwise not suitable for surgical resection with curative intent
  • Scheduled to begin therapy
  • The time interval between 18F FSPG PET/CT and standard of care imaging (ie, 18F FDG PET/CT, diagnostic CT, or MRI) should be within 4 weeks (exceptions will be allowed for 6 weeks, if there are no other options)
  • Ideally, there should be no chemotherapy, radiotherapy, or immune/biologic therapy or biopsy between other imaging (PET/CTs, MRI, or diagnostic CTs) and 18F FSPG PET/CT scheduled or performed (exceptions by investigator discretion)
  • No clinically relevant deviations in renal function (serum creatinine > grade 2 Common Terminology Criteria for Adverse Events [CTCAE] version 4.0); maximal interval between confirmation of renal function and injection of 18F FSPG is 1 week

Exclusion Criteria:

  • Scheduled for surgery and/or another invasive procedure (except biopsy) within the time period of 1 month prior to 18F FSPG administration
  • Known sensitivity to 18F FSPG or components of the preparation
  • Investigator precludes participation for scientific reasons, for reasons of compliance, or for reasons of the patient's safety

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 18F-FSPG and 18F-FDG Intragroup Comparision
Participants sequentially receive radioimaging agents 18F-FSPG and 18F-FDG IV followed by PET/CT scan with 60 minutes.
Drug: 18F-FSPG
Administered intravenously (IV)
Other Names:
  • BAY94-9392
  • 18F-labeled (S)-4-(3-[18F]-fluoropropyl)-L-glutamic acid
  • 18F-labeled (4S)-4-(3-[18F]-fluoropropyl)-L-glutamate
Drug: 18F-FDG
Administered intravenously (IV)
Other Names:
  • [18F]-Fluorodeoxyglucose ([18F]-FDG)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in Standard Uptake Value Maximum (SUVmax) Post-treatment
Time Frame: Baseline and up to 2 years
Standard Uptake Values (SUVs) for the radiotracers labels 18F-FSPG and 18F-FDG were assessed in tumor tissues of study participants, before (baseline), and after therapeutic treatment. Time frame was specified by protocol as at baseline, and at the time of clinical assessments during individual patient regular medical care. The time of the post-treatment assessment was not otherwise explicitly defined but could be anytime within 2 years. The outcome is reported as the difference of means from baseline to post-treatment (a number without dispersion), for all lesions for which an SUVmax value was assessed. A negative result indicates less uptake of radiotracer suggesting a small volume of tumor.
Baseline and up to 2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Treatment-Related Adverse Events
Time Frame: Baseline to up to 2 years
Safety and tolerability of 18F-FSPG and 18F-FDG were assessed as treatment-related adverse events, and reported as the number of events related to each treatment, without dispersion.
Baseline to up to 2 years
Change From Baseline in Lesion Size Post-treatment, by 18F-FSPG or 18F-FDGs
Time Frame: Baseline and up to 2 years
Lesion size in centimeters (cm) were assessed in 2 dimensions from the computed tomography (CT) component of PET/CT and the area in cm2 calculated for lesion locations at baseline and after treatment. Time frame was specified by protocol as at baseline, and at the time of clinical assessments during individual patient regular medical care. The time of the post-treatment assessment was not otherwise explicitly defined but could be anytime within 2 years. The outcome is reported the difference in area in cm² for each lesion (a number without dispersion).
Baseline and up to 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Andrei Iagaru

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Andrei M Iagaru, MD, Stanford University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

  • Park P, Hatami N, Rutledge O, Koglin N, Loo B, Fan A, Mittra E. J Nucl Med. 58(suppl 1, no 118), 1 May 2017.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

July 1, 2015

Primary Completion (ACTUAL)

December 14, 2016

Study Completion (ACTUAL)

December 14, 2016

Study Registration Dates

First Submitted

November 1, 2015

First Submitted That Met QC Criteria

November 4, 2015

First Posted (ESTIMATE)

November 6, 2015

Study Record Updates

Last Update Posted (ACTUAL)

January 3, 2019

Last Update Submitted That Met QC Criteria

December 11, 2018

Last Verified

December 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB-31855
  • P30CA124435 (U.S. NIH Grant/Contract)
  • NCI-2015-01125 (REGISTRY: CTRP (Clinical Trial Reporting Program))
  • VARIMG0006 (OTHER: OnCore ID)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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