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

NCT03144622 | Unknown

• 1 other identifier: 201412135MINC
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Pulmonary Cancer; Breast Neoplasms; Abdominal Cancer

Keywords

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

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (2)

• Uptake of 18F-FSPG

  3 years

• Safety of 18F-FSPG PET/CT

  3 years

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan University Hospital

Taipei, 100, Taiwan

RECRUITING

MeSH Terms

Conditions

Lung Neoplasms; Breast Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Mei-Fang Cheng, MD

  National Taiwan University Hospital Department of Nuclear Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mei-Fang Cheng, MD

CONTACT

886-02-23123456; meifang@ntuh.gov.tw

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 26, 2017
• First Posted: May 9, 2017
• Study Start: September 6, 2016
• Primary Completion: December 31, 2019
• Study Completion: December 31, 2022
• Last Updated: October 30, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)