Clinical trial · Interventional
[18F]ISO-1 Positron Emission Tomography (PET/CT) in Primary Breast Cancer
Imaging of In Vivo Sigma-2 Receptor Expression With [18F]ISO-1 Positron Emission Tomography (PET/CT) in Primary Breast Cancer
NCT02284919CI-TRIAL-00100529ISO-1Primaryactive not recruitingPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
In this study, positron emission tomography (PET/CT) imaging will be used to evaluate sigma-2 (σ2) receptor activity in sites of primary breast cancer using the investigational radiotracer \[18F\]ISO-1.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Breast Neoplasm | Breast Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| [18F]ISO-1 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- ISO-1 PET/CT
- description
- All subjects will receive an \[18F\]ISO-1 PET/CT scan
- interventionNames
- Drug: [18F]ISO-1
Primary outcomes (1)
- measure
- Correlate [18F]ISO-1 uptake with pathologic assays measuring cellular proliferation rates (e.g. Ki-67)
- timeFrame
- 6 years
- description
- Correlate \[18F\]ISO-1 uptake with pathologic assays measuring cellular proliferation rates (e.g. Ki-67)
Secondary outcomes (6)
- measure
- Evaluate the feasibility of using [18F]ISO-1 to image sigma-2 receptor binding in breast cancer
- timeFrame
- 6 years
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Adult patients, at least 18 years of age 2. Known or suspected breast cancer with at least one breast lesion that is 1 cm or greater in size by standard imaging (e.g. mammography, ultrasound or breast MRI) 3. Participants must be informed of the investigational nature of this study and provide written informed consent in accordance with institutional and federal guidelines prior to study-specific procedures Exclusion Criteria: 1. 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. 2. Inability to tolerate imaging procedure in the opinion of an investigator or treating physician 3. 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. 4. Unwilling or unable to provide informed consent.
References
Publications (1)
- DERIVEDMcDonald ES, Doot RK, Young AJ, Schubert EK, Tchou J, Pryma DA, Farwell MD, Nayak A, Ziober A, Feldman MD, DeMichele A, Clark AS, Shah PD, Lee H, Carlin SD, Mach RH, Mankoff DA. Breast Cancer 18F-ISO-1 Uptake as a Marker of Proliferation Status. J Nucl Med. 2020 May;61(5):665-670. doi: 10.2967/jnumed.119.232363. Epub 2019 Dec 13. PMID 31836680