Pulmonary CancerNCT03144622
18F-FSPG PET/CT Imaging in Patients With Cancers
An observational study of Pulmonary Cancer and Breast Neoplasms, run by National Taiwan University Hospital at 1 site in Taiwan.
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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Pulmonary Cancer, Breast Neoplasms, Abdominal Cancer
- How many people
- 120 participants
- Where
- 1 siteTaiwan
- Study dates
- 6 Sep 2016to 31 Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with clinical diagnosis of NSCLC, breast, and abdominal cancers
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Hospital
Taipei, 100
Mei-Fang Cheng, MD, 886-02-23123456 ext. 65901, meifang@ntuh.gov.tw
About this study
Official title: (4S)-4-(3-[18F]Fluoropropyl)-L-glutamate Radiotracer (FSPG) PET/CT for Imaging xC- Transporter Activity in Cancers
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
- Medical subject headings
- Lung Neoplasms, Breast Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 3 years
Secondary outcomes (2)
Uptake of 18F-FSPG
Standardised uptake values (SUV) will be compared between 18F-FSPG and 18F-FDG
Measured: 3 years
Safety of 18F-FSPG PET/CT
Number of reported adverse events
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2017
- Study start6 Sep 2016
- Primary completion31 Dec 2019 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary CancerStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mei-Fang Cheng, MD, Principal investigator, National Taiwan University Hospital Department of Nuclear Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03144622
- Sponsor's protocol ID
- 201412135MINC
- Status last verified
- Oct 2019
- First submitted
- 26 Apr 2017
- Last updated
- 30 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- (4S)-4-(3-[18F]Fluoropropyl)-L-glutamate Radiotracer (FSPG) PET/CT for Imaging xC- Transporter Activity in Cancers
- ClinicalTrials.gov ID
- NCT03144622
- Acronym / sponsor ID
- 201412135MINC
- Conditions
- Pulmonary Cancer, Breast Neoplasms, Abdominal Cancer
- Keywords
- (4S)-4-(3-[18F]fluoropropyl-)-L-glutamate, 18F-FSPG, PET/CT, system xC-transporter
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 6 Sep 2016 (actual)
- Primary completion
- 31 Dec 2019 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 9 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with clinical diagnosis of NSCLC, breast, and abdominal cancers
Key inclusion criteria (7 listed)
- Patients are given the opportunity to participate in the study if
Key exclusion criteria (6 listed)
- Patients with any of the following conditions will be excluded
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Staging ability of 18F-FSPG PET/CT
Time frame: 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
Time frame: 3 years
Comparison between 18F-FSPG and 18F-FDG PET/CT will be done using both qualitative and quantitative measures
2 secondary outcomes
Uptake of 18F-FSPG
Time frame: 3 years
Safety of 18F-FSPG PET/CT
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mei-Fang Cheng, MD principal investigator
National Taiwan University Hospital Department of Nuclear Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pulmonary Cancer and Breast Neoplasms, run by National Taiwan University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mei-Fang Cheng, MD (886-02-23123456 ext. 65901, meifang@ntuh.gov.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Staging ability of 18F-FSPG PET/CT (time frame: 3 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2019.