Clinical trial · Observational
Imaging of in Vivo Sigma-2 Receptor Expression With 18F-ISO-1 Positron Emission Tomography in Metastatic Breast Cancer
NCT03057743CI-TRIAL-00055092terminatedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Difficulty enrolling subjects
Summary
Brief summary (as posted)
Pilot study using \[18F\]ISO-1 PET/CT to image sigma-2 receptor binding in metastatic breast cancer. Correlate baseline uptake and change in uptake after therapy with time to progression and standard and experimental pathology assays of biopsy or surgical tissue. The target population is up to 30 adult patients at least 18 years, with at least one site of disease outside the liver by at least one type of standard imaging.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| METASTATIC BREAST CANCER | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Positron emission tomography (PET/CT) imaging | Device | — | UNRESOLVED |
| radiotracer [18F]ISO-1 | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Progression free survival
- timeFrame
- 3 years
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * At least 18 years of age * Biopsy proven or clinically documented metastatic breast cancer with at least one lesion outside the liver by standard imaging (e.g. CT, MRI, Bone Scan, Ultrasound, FDG PET/CT) * Plan to start new systemic therapy for metastatic disease. * Participants must be informed of the investigational nature of this study and be willing to provide written informed consent and participate in this study in accordance with institutional and federal guidelines prior to study-specific procedures. Exclusion Criteria: * Females who are pregnant at the time of screening will not be eligible for this study, urine or serum pregnancy test will be performed in women of child-bearing potential at the time of screening. * Inability to tolerate imaging procedure in the opinion of an investigator or treating physician. * Serious or unstable medical or psychological conditions that, in the opinion of the investigator, would compromise the subject's safety or successful participation in the study.
References
Publications (0)
Data not yet available
No reference posted for this study.