Trial · NCT07910474
FES PET/MRI for Occult Disease in Lobular Breast Cancer
NCT07910474, Phase 4, Recruiting, University of Wisconsin, Madison
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. FES PET/MRI for Occult Disease in Lobular Breast Cancer. Trials, record NCT07910474. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07910474
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- FES PET/MRI for Occult Disease in Lobular Breast Cancer
- NCT number
- NCT07910474
- Status
- Recruiting
- Phases
- Phase 4
- Enrollment
- 30 participants, estimated
- Lead sponsor
- University of Wisconsin, Madison
- Conditions
- Lobular Breast Carcinoma
- Interventions
- 18Fluoroestradiol (18F-FES), MRI, Gadolinium-based contrast agent (GBCA)
- First posted
- 2026-11-02
- Last updated
- 2026-11-10
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percent of Participants where Disease is Detected using 18F-FES-PET/MRI | up to 6 months | The number of participants for which disease is detected using 18F-FES-PET/MRI compared to the number of samples identified with disease (histopathology) will be reported to estimate the sensitivity of 18F-FES-PET/MRI for detecting disease that is occult (hidden) on SOC imaging. |
| Secondary | Participant Level Positive Predictive Value (PPV) | up to 6 months | Defined by histopathology as the reference standard. This is the odds of 18F-FES-PET/MRI imaging predicting disease. |
| Secondary | Proportion of Participants Upstaged using a composite of the T, N, and M stages | up to 6 months | A cancer is staged by describing the: the size of the Tumor, whether the cancer has spread to lymph Nodes, and whether the cancer has spread to other organs, or Metastasized (TNM staging). TNM upstaging is when a patient is discovered to have more advanced cancer than initially imaging. |
| Secondary | Proportion of patients who are diagnosed with pathology-proven multifocal, multicentric or contralateral disease | up to 6 months | The proportion of patients who are diagnosed with pathology-proven multifocal, multicentric or contralateral disease will be measured to characterize the frequency of the detection of extensive breast involvement by 18F-FES-PET/MRI. |
| Secondary | Percent of participants where 18F-FES-PET/MRI changed clinical care compared to SOC image | up to 6 months | The following will be reviewed: frequency of changes in treatment intent from curative to palliative after detecting occult metastatic disease; conversion to neoadjuvant therapy after detecting occult locally advanced disease; and changes in axillary surgery from sentinel lymph node biopsy to targeted axillary dissection or complete axillary lymph node dissection after detecting occult axillary metastases in order to characterize the clinical impact of 18F-FES-PET/MRI on treatment decision. |
| Secondary | Lesion-level agreement of the maximal tumor dimension | up to 6 months | The lesion-level agreement of the maximal tumor dimension for the indexed ILC lesion, comparing imaging measurements with pathology measurements among patients who underwent definitive surgery will be reported to characterize the agreement of ILC tumor size between imaging exams (18F FES PET-MRI and SOC breast MRI, ultrasound and mammogram) and histopathologic exams. |
| Secondary | Lesion-level error rate in maximal tumor dimension | up to 6 months | The lesion-level error rate in maximal tumor dimension using pre-specified relative threshold of less than or equal to 25 percent difference between imaging and pathology measurements will be reported to characterize the error rate in size measurements between radiology and pathology for primary ILC. |
| Secondary | Percent of participants where 18F-FES-PET/MRI changed surgical planning | up to 6 months | The frequency of changed surgical planning (conversion from planned lumpectomy to mastectomy due to extensive breast involvement; margin re-excision in those undergoing lumpectomy; conversion to mastectomy in those initially managed with lumpectomy) will be reported to characterize the clinical impact of 18F-FES-PET/MRI on surgical planning. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT07910474
GET https://conductscience.org/api/trials/v1/NCT07910474/registered