Identify FDG PET/CT Parameters Predictive of Local ControlMUMOFRAT retroNCT06555861
Local Recurrence Prediction of by Texture Analysis Derived From Positron Emission Tomography (PET / CT) Imaging of Non-small Cell Lung Cancer (NSCLC) Treated With Stereotactic Radiotherapy (SBRT) (Retros MUMOFRAT)
An observational study of Identify FDG PET/CT Parameters Predictive of Local Control, run by University Hospital, Brest at 4 sites in France.
Trial summary
The aim of this retrospective multicentric study was to develop and evaluate a prognostic FDG PET/CT radiomics signature in early-stage non-small cell lung cancer (NSCLC) patients treated with stereotactic radiotherapy (SBRT). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Identify FDG PET/CT Parameters Predictive of Local Control
- How many people
- 87 participants
- Where
- 4 sitesFrance
- Study dates
- 7 Jan 2019to 6 Feb 2019
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Eighty-seven patients with NSCLC stage I-II and tumours diameters below 5 cm according to the 8th American Joint Committee on Cancer classification, treated with definitive curative SBRT from January 2012 to December 2016 at 4 French institutions (Rennes, Tours, Brest and Nantes) were retrospectively included.
Who may be able to join
- NSCLC stage I-II treated by SBRT
- PET/CT imaging performed within 60 days of SBRT
Who cannot join
- Lack of follow-up
- Refusal of consent
Trial locations and contacts
4 sites in 1 country.
France4 sites
CHRU de Brest
Brest, 29609
ICO
Nantes, Saint Herblain, 44800
Centre Eugènes Marquis
Rennes, 35042
CHU de Tours
Tours, 37000
About this study
Official title: Local Recurrence Prediction of by Texture Analysis Derived From Positron Emission Tomography (PET / CT) Imaging of Non-small Cell Lung Cancer (NSCLC) Treated With Stereotactic Radiotherapy (SBRT)
The aim of this retrospective multicentric study was to develop and evaluate a prognostic FDG PET/CT radiomics signature in early-stage non-small cell lung cancer (NSCLC) patients treated with stereotactic radiotherapy (SBRT).
- Keywords
- PET/CT, Radiomics, Early-stage NSCLC, Stereotactic radiotherapy
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What is being measured
The primary outcome is the main question the study is designed to answer.
Local Recurrence
accuracy
Measured: Time-to-Event measures up to 5 years
Secondary outcomes (4)
Cancer specific survival
accuracy
Measured: Time-to-Event measures up to 5 years
Distant metastasis free survival
accuracy
Measured: Time-to-Event measures up to 5 years
Recurrence free survival
accuracy
Measured: Time-to-Event measures up to 5 years
Overall survival
accuracy
Measured: Time-to-Event measures up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2024
- Study start7 Jan 2019
- Primary completion6 Feb 2019
- Study completion6 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Identify FDG PET/CT Parameters Predictive of Local ControlStudies of the same condition, open and under way.
- More trials run by University Hospital, BrestThe 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
- Retrospective
- Enrolment
- 87 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Brest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06555861
- Sponsor's protocol ID
- 29BRC18.0283 - Retros MUMOFRAT
- Acronym
- MUMOFRAT retro
- Status last verified
- Dec 2018
- First submitted
- 13 Aug 2024
- Last updated
- 15 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Local Recurrence Prediction of by Texture Analysis Derived From Positron Emission Tomography (PET / CT) Imaging of Non-small Cell Lung Cancer (NSCLC) Treated With Stereotactic Radiotherapy (SBRT)
- ClinicalTrials.gov ID
- NCT06555861
- Acronym / sponsor ID
- MUMOFRAT retro / 29BRC18.0283 - Retros MUMOFRAT
- Keywords
- PET/CT, Radiomics, Early-stage NSCLC, Stereotactic radiotherapy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 87 participants (actual)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Study start
- 7 Jan 2019 (actual)
- Primary completion
- 6 Feb 2019 (actual)
- Study completion
- 6 Feb 2019 (actual)
- First posted
- 15 Aug 2024 (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.
The aim of this retrospective multicentric study was to develop and evaluate a prognostic FDG PET/CT radiomics signature in early-stage non-small cell lung cancer (NSCLC) patients treated with stereotactic radiotherapy (SBRT).
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Eighty-seven patients with NSCLC stage I-II and tumours diameters below 5 cm according to the 8th American Joint Committee on Cancer classification, treated with definitive curative SBRT from January 2012 to December 2016 at 4 French institutions (Rennes, Tours, Brest and Nantes) were retrospectively included.
Key inclusion criteria (2 listed)
- NSCLC stage I-II treated by SBRT
- PET/CT imaging performed within 60 days of SBRT
Key exclusion criteria (2 listed)
- Lack of follow-up
- Refusal of consent
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
Local Recurrence
Time frame: Time-to-Event measures up to 5 years
accuracy
4 secondary outcomes
Cancer specific survival
Time frame: Time-to-Event measures up to 5 years
Distant metastasis free survival
Time frame: Time-to-Event measures up to 5 years
Recurrence free survival
Time frame: Time-to-Event measures up to 5 years
Overall survival
Time frame: Time-to-Event measures up to 5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2024.
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.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Identify FDG PET/CT Parameters Predictive of Local Control, run by University Hospital, Brest at 4 sites in France.
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 2 inclusion and 2 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: finished, as of the sponsor's last update on 15 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in France. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Local Recurrence (time frame: Time-to-Event measures up to 5 years). 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 15 Aug 2024.