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

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ClinicalTrials.gov Identifier: NCT02599194
Recruitment Status : Completed
First Posted : November 6, 2015
Results First Posted : January 3, 2019
Last Update Posted : January 3, 2019
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Andrei Iagaru, Stanford University

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.

Condition or disease Intervention/treatment Phase
B-Cell Neoplasm Estrogen Receptor Negative HER2/Neu Negative Metastatic Renal Cell Cancer Progesterone Receptor Negative Stage III Mesothelioma Stage III Renal Cell Cancer Stage IIIA Breast Cancer Stage IIIA Non-Small Cell Lung Cancer Stage IIIB Non-Small Cell Lung Cancer Stage IIIC Breast Cancer Stage IV Breast Cancer Stage IV Mesothelioma Stage IV Non-Small Cell Lung Cancer Stage IV Renal Cell Cancer Triple-Negative Breast Carcinoma Drug: 18F-FSPG Drug: 18F-FDG Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 7 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Intra-patient comparison of 2 different radiolabels
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: An Exploratory Study of the Role of 18F-FSPG PET/CT Imaging for Cancer Patients Receiving Therapy
Actual Study Start Date : July 2015
Actual Primary Completion Date : December 14, 2016
Actual Study Completion Date : December 14, 2016


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:
  • 18F-labeled (S)-4-(3-[18F]-fluoropropyl)-L-glutamic acid
  • 18F-labeled (4S)-4-(3-[18F]-fluoropropyl)-L-glutamate
  • BAY94-9392

Drug: 18F-FDG
Administered intravenously (IV)
Other Name: [18F]-Fluorodeoxyglucose ([18F]-FDG)




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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).



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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): NCT02599194


Locations
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United States, California
Stanford University Medical Center
Stanford, California, United States, 94304
Sponsors and Collaborators
Andrei Iagaru
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Andrei M Iagaru, MD Stanford University

Publications of Results:
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.

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Responsible Party: Andrei Iagaru, Associate Professor of Radiology, Stanford University
ClinicalTrials.gov Identifier: NCT02599194     History of Changes
Other Study ID Numbers: IRB-31855
NCI-2015-01125 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
VARIMG0006 ( Other Identifier: OnCore ID )
P30CA124435 ( U.S. NIH Grant/Contract )
First Posted: November 6, 2015    Key Record Dates
Results First Posted: January 3, 2019
Last Update Posted: January 3, 2019
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Breast Neoplasms
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Mesothelioma
Carcinoma, Renal Cell
Triple Negative Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Adenoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms, Mesothelial
Adenocarcinoma
Carcinoma
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Kidney Diseases
Urologic Diseases
Fluorodeoxyglucose F18
Radiopharmaceuticals
Molecular Mechanisms of Pharmacological Action