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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01062100

Acronym

THORN

Enrollment

Registered

2010-02-04

Start date

2010-02-28

Completion date

2013-02-28

Last updated

2013-02-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

Keywords

breast cancer, molecular breast imaging, MRI, gamma camera

Brief summary

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

Interventions

DEVICEnuclear breast imaging using MBI Gamma camera

nuclear breast imaging using MBI Gamma camera in addition to MRI

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
To assess the feasibility, safety and acceptability to patients of the MBI Gamma camera.	1 year

Secondary

Measure	Time frame
To explore the ability of the MBI Gamma camera to detect breast cancer.	1 year

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026