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

• Conditions: Abdominal Cancer; Breast Neoplasms; Pulmonary Cancer

• Registration Number: NCT03144622
• Lead Sponsor: National Taiwan University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-09-06
• Study First Submitted: 2017-04-26
• Study First Submitted QC: 2017-05-04
• Study First Posted: 2017-05-09
• Status Verified: 2019-10
• Last Update Submitted: 2019-10-29
• Last Update Posted: 2019-10-30
• Primary Completion: 2019-12-31
• Study Completion: 2022-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

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

Trial Locations

Locations (1)

National Taiwan University Hospital; 🇨🇳 Taipei, Taiwan