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

Study 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.

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Key things to know

Main goalDiagnostic

This describes the study’s primary purpose.

What is being studied18F-FSPG and 18F-FDG

The study team can explain what participation involves.

Who it may be forNon-small cell lung cancer (NSCLC) · Mesothelioma · Locally advanced

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Jan 3, 2019 · Source: ClinicalTrials.gov

Is enrollment open?Completed

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 2

Interventional

Where is it offered?1 U.S. location

Locations may change over time.

Who runs it?Andrei Iagaru

Study sponsor

Study overview

What this study is about

Purpose: Diagnostic
Study type: Interventional
Phase: Phase 2
Sponsor: Andrei Iagaru
Interventions being studied: Drug: 18F-FSPG; Drug: 18F-FDG

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How this study is categorized

These labels come from structured fields and exact terms in the public record.

Cancer type

Non-small cell lung cancer (NSCLC)→Mesothelioma→

Disease setting

Locally advanced→Metastatic or stage IV→

Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion 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

Reasons someone may not be able to joinExclusion 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

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

Study sites

U.S. locations

Stanford University Medical CenterStanford, California

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Jan 3, 2019. Always confirm current availability with the study team.

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