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

NCT ID: NCT02599194

Last Updated: 2019-01-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 7 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-07-31
• Study Completion Date: 2016-12-14

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.

Conditions

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

18F-FSPG

Intervention Type: DRUG

Administered intravenously (IV)

18F-FDG

Intervention Type: DRUG

Administered intravenously (IV)

Interventions

18F-FSPG

Administered intravenously (IV)

Intervention Type: DRUG

18F-FDG

Administered intravenously (IV)

Intervention Type: DRUG

Other Intervention Names

18F-labeled (S)-4-(3-[18F]-fluoropropyl)-L-glutamic acid; 18F-labeled (4S)-4-(3-[18F]-fluoropropyl)-L-glutamate; BAY94-9392; [18F]-Fluorodeoxyglucose ([18F]-FDG)

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Andrei Iagaru

OTHER

Sponsor Role: lead

Responsible Party

Andrei Iagaru

Associate Professor of Radiology

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Andrei M Iagaru, MD

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

Stanford University Medical Center

Stanford, California, United States

Countries

United States

References

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.

Reference Type: RESULT

Other Identifiers

NCI-2015-01125

Identifier Type: REGISTRY

Identifier Source: secondary_id

VARIMG0006

Identifier Type: OTHER

Identifier Source: secondary_id

P30CA124435

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IRB-31855

Identifier Type: -

Identifier Source: org_study_id