Clinical trial NCT02599194: 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
Overall status: COMPLETED
Phase: PHASE2
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
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2015-11-06
Enrollment: 7
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Intra-patient comparison of 2 different radiolabels
Primary purpose: DIAGNOSTIC

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.

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

Primary outcomes:
measure: Change From Baseline in Standard Uptake Value Maximum (SUVmax) Post-treatment
timeFrame: Baseline and up to 2 years
Secondary outcomes:
measure: Number of Treatment-Related Adverse Events
timeFrame: Baseline to up to 2 years
measure: Change From Baseline in Lesion Size Post-treatment, by 18F-FSPG or 18F-FDGs
timeFrame: Baseline and up to 2 years
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University Medical Center
state: California
Study officials:
affiliation: Stanford University
name: Andrei M Iagaru, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.