NCT02599194

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
7

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Jul 2015

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2015

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

November 1, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 6, 2015

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 14, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 14, 2016

Completed
2.1 years until next milestone

Results Posted

Study results publicly available

January 3, 2019

Completed
Last Updated

January 3, 2019

Status Verified

December 1, 2018

Enrollment Period

1.5 years

First QC Date

November 1, 2015

Results QC Date

September 20, 2018

Last Update Submit

December 11, 2018

Conditions

B-Cell NeoplasmEstrogen Receptor NegativeHER2/Neu NegativeMetastatic Renal Cell CancerProgesterone Receptor NegativeStage III MesotheliomaStage III Renal Cell CancerStage IIIA Breast CancerStage IIIA Non-Small Cell Lung CancerStage IIIB Non-Small Cell Lung CancerStage IIIC Breast CancerStage IV Breast CancerStage IV MesotheliomaStage IV Non-Small Cell Lung CancerStage IV Renal Cell CancerTriple-Negative Breast Carcinoma

Outcome Measures

Primary Outcomes (1)

  • Change From Baseline in Standard Uptake Value Maximum (SUVmax) Post-treatment

    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 Outcomes (2)

  • Number of Treatment-Related Adverse Events

    Baseline to up to 2 years

  • Change From Baseline in Lesion Size Post-treatment, by 18F-FSPG or 18F-FDGs

    Baseline and up to 2 years

Study Arms (1)

18F-FSPG and 18F-FDG Intragroup Comparision

EXPERIMENTAL

Participants sequentially receive radioimaging agents 18F-FSPG and 18F-FDG IV followed by PET/CT scan with 60 minutes.

Drug: 18F-FSPGDrug: 18F-FDG

Interventions

18F-FSPGDRUG

Administered intravenously (IV)

Also known as: 18F-labeled (S)-4-(3-[18F]-fluoropropyl)-L-glutamic acid, 18F-labeled (4S)-4-(3-[18F]-fluoropropyl)-L-glutamate, BAY94-9392
18F-FSPG and 18F-FDG Intragroup Comparision
18F-FDGDRUG

Administered intravenously (IV)

Also known as: [18F]-Fluorodeoxyglucose ([18F]-FDG)
18F-FSPG and 18F-FDG Intragroup Comparision

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stanford University Medical Center

Stanford, California, 94304, United States

Location

Related Publications (1)

  • 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.

    RESULT

MeSH Terms

Conditions

Lymphoma, B-CellCarcinoma, Renal CellMesotheliomaBreast NeoplasmsCarcinoma, Non-Small-Cell LungTriple Negative Breast Neoplasms

Interventions

4-(3-fluoropropyl)glutamic acid(4S)-4-(3-(18F)fluoropropyl)-L-glutamateFluorodeoxyglucose F18

Condition Hierarchy (Ancestors)

Lymphoma, Non-HodgkinLymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesAdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialKidney NeoplasmsUrologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesKidney DiseasesUrologic DiseasesMale Urogenital DiseasesAdenomaNeoplasms, MesothelialBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesCarcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

DeoxyglucoseDeoxy SugarsCarbohydrates

Results Point of Contact

Title
Andrei H. Iagaru
Organization
Stanford University
aiagaru@stanford.edu
(650) 725-4711

Study Officials

  • Andrei M Iagaru, MD

    Stanford University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Model Details: Intra-patient comparison of 2 different radiolabels
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Associate Professor of Radiology

Study Record Dates

First Submitted

November 1, 2015

First Posted

November 6, 2015

Study Start

July 1, 2015

Primary Completion

December 14, 2016

Study Completion

December 14, 2016

Last Updated

January 3, 2019

Results First Posted

January 3, 2019

Record last verified: 2018-12

Data Sharing

IPD Sharing
Will not share

Locations

US(1)