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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03144622
Other study ID # 201412135MINC
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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.

Study Design


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
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