18F-FSPG PET/CT Imaging in Patients With Cancers

October 29, 2019 updated by: National Taiwan University Hospital

(4S)-4-(3-[18F]Fluoropropyl)-L-glutamate Radiotracer (FSPG) PET/CT for Imaging xC- Transporter Activity in Cancers

This study aims to compare the diagnostic performance of 18F-FDG and 18F-FSPG PET/CT in lung, breast, and abdominal cancers before undergoing therapy. In addition, the role of 18F-FSPG PET/CT in evaluating therapy response and prognosis will also be evaluated.

Study Overview

Status

Unknown

Conditions

Study Type

Observational

Enrollment (Anticipated)

120

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Taiwan
      • Taipei, Taiwan, 100
        • Recruiting
        • National Taiwan University Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with clinical diagnosis of NSCLC, breast, and abdominal cancers

Description

Inclusion Criteria:

  • Patients are given the opportunity to participate in the study if

    1. Age ≥ 20 years old.
    2. Confirmed diagnosis of primary cancer of the following: NSCLC, breast or abdominal cancers
    3. ECOG performance status 0 to 2.
    4. Life expectancy > 3 months.
    5. Consent to perform additional 18F-FSPG and 18F-FDG PET prior to therapy.
    6. Sexually active subjects agree to use condoms and/or their partners of reproductive potential to use a method of effective birth control during imaging period of 2 weeks.

Exclusion Criteria:

  • Patients with any of the following conditions will be excluded

    1. Had received previous treatment (excluding neoadjuvant therapy).
    2. Pregnant or lactating women.
    3. Known malignancy in other organs.
    4. Evaluated by primary care physician as unsuitable.
    5. Known hypersensitivity to the study drug.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Staging ability of 18F-FSPG PET/CT
Time Frame: 3 years
Sensitivity, specificity, diagnostic accuracy of 18F-FSPG and 18F-FDG PET/CT will be compared according to patient-based and lesion-based analysis using paired t-test or Krusal-Wallis test.
3 years
Ability of 18F-FSPG PET/CT in therapy response evaluation and prognosis prediction
Time Frame: 3 years
Comparison between 18F-FSPG and 18F-FDG PET/CT will be done using both qualitative and quantitative measures
3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Uptake of 18F-FSPG
Time Frame: 3 years
Standardised uptake values (SUV) will be compared between 18F-FSPG and 18F-FDG
3 years
Safety of 18F-FSPG PET/CT
Time Frame: 3 years
Number of reported adverse events
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Taiwan University Hospital

Investigators

  • Principal Investigator: Mei-Fang Cheng, MD, National Taiwan University Hospital Department of Nuclear Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 6, 2016

Primary Completion (Anticipated)

December 31, 2019

Study Completion (Anticipated)

December 31, 2022

Study Registration Dates

First Submitted

April 26, 2017

First Submitted That Met QC Criteria

May 4, 2017

First Posted (Actual)

May 9, 2017

Study Record Updates

Last Update Posted (Actual)

October 30, 2019

Last Update Submitted That Met QC Criteria

October 29, 2019

Last Verified

October 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 201412135MINC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Breast Neoplasms

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Malaysia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe