search
Back to results

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

Primary Purpose

B-Cell Neoplasm, Estrogen Receptor Negative, HER2/Neu Negative

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
18F-FSPG
18F-FDG
Sponsored by
Andrei Iagaru
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for B-Cell Neoplasm

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Stanford University Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

18F-FSPG and 18F-FDG Intragroup Comparision

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Number of Treatment-Related Adverse Events
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.
Change From Baseline in Lesion Size Post-treatment, by 18F-FSPG or 18F-FDGs
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).

Full Information

First Posted
November 1, 2015
Last Updated
December 11, 2018
Sponsor
Andrei Iagaru
Collaborators
National Cancer Institute (NCI)
search

1. Study Identification

Unique Protocol Identification Number
NCT02599194
Brief Title
18F-FSPG PET/CT for Cancer Patients on Therapy
Official Title
An Exploratory Study of the Role of 18F-FSPG PET/CT Imaging for Cancer Patients Receiving Therapy
Study Type
Interventional

2. Study Status

Record Verification Date
December 2018
Overall Recruitment Status
Completed
Study Start Date
July 2015 (Actual)
Primary Completion Date
December 14, 2016 (Actual)
Study Completion Date
December 14, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Andrei Iagaru
Collaborators
National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Model Description
Intra-patient comparison of 2 different radiolabels
Masking
None (Open Label)
Allocation
N/A
Enrollment
7 (Actual)

8. Arms, Groups, and Interventions

Arm Title
18F-FSPG and 18F-FDG Intragroup Comparision
Arm Type
Experimental
Arm Description
Participants sequentially receive radioimaging agents 18F-FSPG and 18F-FDG IV followed by PET/CT scan with 60 minutes.
Intervention Type
Drug
Intervention Name(s)
18F-FSPG
Other Intervention Name(s)
18F-labeled (S)-4-(3-[18F]-fluoropropyl)-L-glutamic acid, 18F-labeled (4S)-4-(3-[18F]-fluoropropyl)-L-glutamate, BAY94-9392
Intervention Description
Administered intravenously (IV)
Intervention Type
Drug
Intervention Name(s)
18F-FDG
Other Intervention Name(s)
[18F]-Fluorodeoxyglucose ([18F]-FDG)
Intervention Description
Administered intravenously (IV)
Primary Outcome Measure Information:
Title
Change From Baseline in Standard Uptake Value Maximum (SUVmax) Post-treatment
Description
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.
Time Frame
Baseline and up to 2 years
Secondary Outcome Measure Information:
Title
Number of Treatment-Related Adverse Events
Description
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.
Time Frame
Baseline to up to 2 years
Title
Change From Baseline in Lesion Size Post-treatment, by 18F-FSPG or 18F-FDGs
Description
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).
Time Frame
Baseline and up to 2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrei M Iagaru, MD
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stanford University Medical Center
City
Stanford
State/Province
California
ZIP/Postal Code
94304
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
Citation
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.
Results Reference
result

Learn more about this trial

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

We'll reach out to this number within 24 hrs