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

Sponsor

National Taiwan University Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT03144622

Collaborator

(none)

120

Enrollment

Location

75.8

Anticipated Duration (Months)

1.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Pulmonary Cancer Breast Neoplasms Abdominal Cancer

Study Design

Study Type:

Observational

Anticipated Enrollment :

120 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Sep 6, 2016

Anticipated Primary Completion Date :

Dec 31, 2019

Anticipated Study Completion Date :

Dec 31, 2022

Outcome Measures

Primary Outcome Measures

Staging ability of 18F-FSPG PET/CT [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.
Ability of 18F-FSPG PET/CT in therapy response evaluation and prognosis prediction [3 years]
Comparison between 18F-FSPG and 18F-FDG PET/CT will be done using both qualitative and quantitative measures

Secondary Outcome Measures

Uptake of 18F-FSPG [3 years]
Standardised uptake values (SUV) will be compared between 18F-FSPG and 18F-FDG
Safety of 18F-FSPG PET/CT [3 years]
Number of reported adverse events

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Patients are given the opportunity to participate in the study if

Age ≥ 20 years old.
Confirmed diagnosis of primary cancer of the following: NSCLC, breast or abdominal cancers
ECOG performance status 0 to 2.
Life expectancy > 3 months.
Consent to perform additional 18F-FSPG and 18F-FDG PET prior to therapy.
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

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	National Taiwan University Hospital	Taipei		Taiwan	100

Sponsors and Collaborators

National Taiwan University Hospital

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

National Taiwan University Hospital

ClinicalTrials.gov Identifier:

NCT03144622

Other Study ID Numbers:

201412135MINC

First Posted:

May 9, 2017

Last Update Posted:

Oct 30, 2019

Last Verified:

Oct 1, 2019

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by National Taiwan University Hospital

(4S)-4-(3-[18F]fluoropropyl-)-L-glutamate

18F-FSPG

PET/CT

system xC-transporter

Additional relevant MeSH terms:

Breast Neoplasms

Lung Neoplasms

Study Results

No Results Posted as of Oct 30, 2019