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

Breast Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03144622
• Other study ID #: 201412135MINC
• Status: Recruiting
• Start date: September 6, 2016
• Est. completion date: December 31, 2022

Study information

• Verified date: October 2019
• Source: National Taiwan University Hospital
• Contact: Mei-Fang Cheng, MD
• Phone: 886-02-23123456
• Email: meifang[@]ntuh.gov.tw
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Abdominal Cancer
• Breast Neoplasms
• Lung Neoplasms
• Pulmonary Cancer

Locations

Country	Name	City	State
Taiwan	National Taiwan University Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Staging ability of 18F-FSPG PET/CT	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
Primary	Ability of 18F-FSPG PET/CT in therapy response evaluation and prognosis prediction	Comparison between 18F-FSPG and 18F-FDG PET/CT will be done using both qualitative and quantitative measures	3 years
Secondary	Uptake of 18F-FSPG	Standardised uptake values (SUV) will be compared between 18F-FSPG and 18F-FDG	3 years
Secondary	Safety of 18F-FSPG PET/CT	Number of reported adverse events	3 years