Clinical trial · Interventional
Study To Investigate the Feasibility and Safety of A Dedicated High Resolution Nuclear Breast Imaging Camera
The Hamilton Prospective Pilot Study To Investigate the Feasibility and Safety of A Dedicated High Resolution Nuclear Breast Imaging Camera
NCT01062100CI-TRIAL-00009491THORNcompletedN/AClinicalTrials.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)
To evaluate the feasibility, acceptability and safety of using a molecular breast imaging (MBI) Gamma Camera in women at high risk of developing breast cancer
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 |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| nuclear breast imaging using MBI Gamma camera | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- nuclear breast imaging
- description
- nuclear breast imaging using MBI Gamma camera
- interventionNames
- Device: nuclear breast imaging using MBI Gamma camera
Primary outcomes (1)
- measure
- To assess the feasibility, safety and acceptability to patients of the MBI Gamma camera.
- timeFrame
- 1 year
Secondary outcomes (1)
- measure
- To explore the ability of the MBI Gamma camera to detect breast cancer.
- timeFrame
- 1 year
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Females ≥18 years of age * Undergoing annual breast MRI because of a high risk of breast cancer due to any of the following: * Known BRCA1 or BRCA2 mutation carriers, or is untested for BRCA but is a first degree relative of a BRCA mutation carrier * History of radiation to the chest between 10-30 years of age (e.g. Hodgkin's Disease) * History of Cowdens or Li Fraumeni Syndrome * A first degree relative with Cowdens or Li Fraumeni Syndrome * Prior breast biopsy positive for lobular carcinoma in situ (LCIS) or atypical lobular hyperplasia or atypical ductal hyperplasia (ADH) * Family history consistent with a hereditary breast cancer syndrome and estimated personal lifetime cancer risk ≥25% using the IBIS risk evaluator Exclusion Criteria: * Pregnant or lactating * History of invasive breast cancer or ductal carcinoma in situ (DCIS) * Unable to undergo MRI because of: * Renal dysfunction with an estimated creatinine clearance of \< 30 ml/min calculated using the Cockcroft-Gault formula * Implanted ferrous metal prostheses * Claustrophobia * Medical or psychological conditions that on assessment, make them unable to complete the procedure * Known allergies to Gadolinium-DTPA * Known allergies to Sestamibi (Miraluma or Cardiolite) * Prior bilateral mastectomy * Prior breast biopsy or surgery within 3 months
References
Publications (0)
Data not yet available
No reference posted for this study.