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

Stage IV Breast Cancer Clinical Trial

Official title:

An Exploratory Study of the Role of 18F-FSPG PET/CT Imaging for Cancer Patients Receiving Therapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02599194
• Other study ID #: IRB-31855
• Secondary ID: NCI-2015-01125VA
• Status: Completed
• Phase: Phase 2
• Start date: July 2015
• Est. completion date: December 14, 2016

Study information

• Verified date: December 2018
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7
• Est. completion date: December 14, 2016
• Est. primary completion date: December 14, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• B-Cell Neoplasm
• Breast Neoplasms
• Carcinoma, Non-Small-Cell Lung
• Carcinoma, Renal Cell
• Estrogen Receptor Negative
• HER2/Neu Negative
• Lung Neoplasms
• Lymphoma, B-Cell
• Mesothelioma
• 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 Neoplasms
• Triple-Negative Breast Carcinoma

Intervention

Drug:
• 18F-FSPG
Administered intravenously (IV)
• 18F-FDG
Administered intravenously (IV)

Locations

Country	Name	City	State
United States	Stanford University Medical Center	Stanford	California

Sponsors (2)

Lead Sponsor	Collaborator
Andrei Iagaru	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

References & 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.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	Baseline to up to 2 years
Secondary	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).	Baseline and up to 2 years