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Completed

NCT Number: NCT02599194

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

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.

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Key information

Conditions

B-Cell Neoplasm Adenocarcinoma Adenoma Breast Diseases Breast Neoplasms Bronchial Neoplasms Carcinoma Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Carcinoma, Renal Cell Estrogen Receptor Negative Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications HER2/Neu Negative Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Kidney Diseases Kidney Neoplasms Lung Diseases Lung Neoplasms Lymphatic Diseases Lymphoma Lymphoma, B-Cell Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Male Urogenital Diseases Mesothelioma Metastatic Renal Cell Cancer Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Neoplasms, Mesothelial Progesterone Receptor Negative Respiratory Tract Diseases Respiratory Tract Neoplasms Skin Diseases Skin and Connective Tissue Diseases 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 Thoracic Neoplasms Triple Negative Breast Neoplasms Triple-Negative Breast Carcinoma Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Stanford University Medical Center

Stanford, California, 94304, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

18F-FSPG

Drug

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

18F-FDG

Drug

Administered intravenously (IV)

Other names: [18F]-Fluorodeoxyglucose ([18F]-FDG)

Primary outcomes

  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 outcomes

  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).

Sponsors and collaborators

Lead sponsor

Andrei Iagaru

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Nov 6, 2015
Registry last updated
Jan 3, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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