Oligometastatic Breast CarcinomaNCT07872332
FDG PET/CT Radiomics for True Oligometastatic Breast Cancer
An observational study of Oligometastatic Breast Carcinoma and Radiomics, run by Sohag University.
Trial summary
FDG PET CT Radiomics for True Oligometastatic Breast Cancer Read more about this study
- Who is it for?
- Ages 18 to 90 years, women only
- Conditions the study is for
- Oligometastatic Breast Carcinoma, Radiomics
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2026to 1 Oct 2027
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 to 90 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: True Oligometastatic Disease Group Patients fulfilling both criteria: * Presence of ≤5 metastatic lesions at diagnosis. * Persistence of oligometastatic status for at least 24 months without progression to widespread metastatic disease. Pseudo-Oligometastatic Disease Group Patients fulfilling both criteria: * Presence of ≤5 metastatic lesions at diagnosis. * Progression to >5 metastatic lesions or development of widespread metastatic disease within 24 months of follow-up.
Who may be able to join
- • Female patients aged ≥18 years.
- Histopathologically confirmed breast carcinoma.
- Baseline whole-body ^18F-FDG PET/CT available before initiation of systemic treatment for metastatic disease.
- Presence of oligometastatic disease defined as 1-5 metastatic lesions on baseline imaging.
Who cannot join
- • More than five metastatic lesions at baseline.
- Previous history of another primary malignancy.
- Poor image quality unsuitable for radiomic analysis.
- Incomplete clinical follow-up records.
- Pregnant patients.
About this study
Official title: Whole-Body FDG PET/CT Radiomics as a Biomarker of True Oligometastatic Disease in Breast Cancer.
FDG PET CT Radiomics for True Oligometastatic Breast Cancer
- Conditions
- Oligometastatic Breast Carcinoma, Radiomics
What is being measured
The primary outcome is the main question the study is designed to answer.
Differentiate true oligometastatic from pseudo oligometastatic breast cancer
Measured: 1-2 years
Predictive value of conventional PET/CT metabolic parameters (SUVmax, SUVmean, MTV, and TLG) together with radiomic features
Measured: 1-2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2026
- Study start1 Oct 2026 (estimated)
- Primary completion1 Jun 2027 (estimated)
- Study completion1 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oligometastatic Breast CarcinomaStudies of the same condition, open and under way.
- More trials run by Sohag UniversityThe 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
- Other
- Enrolment
- 100 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shrouk Atef Abdelsalam, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07872332
- Sponsor's protocol ID
- Soh-Med--26-9-1-MD
- Status last verified
- Oct 2026
- First submitted
- 30 Sep 2026
- Last updated
- 13 Oct 2026
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Whole-Body FDG PET/CT Radiomics as a Biomarker of True Oligometastatic Disease in Breast Cancer.
- ClinicalTrials.gov ID
- NCT07872332
- Acronym / sponsor ID
- Soh-Med--26-9-1-MD
- Conditions
- Oligometastatic Breast Carcinoma, Radiomics
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 1 Jun 2027 (estimated)
- Study completion
- 1 Oct 2027 (estimated)
- First posted
- 13 Oct 2026 (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.
FDG PET CT Radiomics for True Oligometastatic Breast Cancer
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 2 Years
Who may qualify
- Ages
- 18 to 90 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- True Oligometastatic Disease Group Patients fulfilling both criteria: * Presence of ≤5 metastatic lesions at diagnosis. * Persistence of oligometastatic status for at least 24 months without progression to widespread metastatic disease. Pseudo-Oligometastatic Disease Group Patients fulfilling both criteria: * Presence of ≤5 metastatic lesions at diagnosis. * Progression to >5 metastatic lesions or development of widespread metastatic disease within 24 months of follow-up.
Key inclusion criteria (4 listed)
- • Female patients aged ≥18 years.
Key exclusion criteria (5 listed)
- • More than five metastatic lesions at baseline.
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
Differentiate true oligometastatic from pseudo oligometastatic breast cancer
Time frame: 1-2 years
Predictive value of conventional PET/CT metabolic parameters (SUVmax, SUVmean, MTV, and TLG) together with radiomic features
Time frame: 1-2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Oligometastatic Breast Carcinoma and Radiomics, run by Sohag University.
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 4 inclusion and 5 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: opening soon, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
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?
Differentiate true oligometastatic from pseudo oligometastatic breast cancer (time frame: 1-2 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 13 Oct 2026.