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

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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03144622

Enrollment

120

Registered

2017-05-09

Start date

2016-09-06

Completion date

2022-12-31

Last updated

2019-10-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Abdominal Cancer, Breast Neoplasms, Pulmonary Cancer

Keywords

(4S)-4-(3-[18F]fluoropropyl-)-L-glutamate, 18F-FSPG, PET/CT, system xC-transporter

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

20 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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

Countries

Taiwan

Contacts

Primary ContactMei-Fang Cheng, MD

meifang@ntuh.gov.tw886-02-23123456

Outcome results