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Accuracy of a Positron Emission Tomography (PET) and Beta Probe in the Staging of Ductal Carcinoma In Situ & Invasive Ductal Cancer of the Breast.

Accuracy of a Positron Emission Tomography (PET) and Beta Probe in the Staging of Ductal Carcinoma In Situ & Invasive Ductal Cancer of the Breast.

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ANZCTR
Registry ID
ACTRN12610000300077
Enrollment
60
Registered
2010-04-15
Start date
2010-04-30
Completion date
Unknown
Last updated
2020-01-13

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

Conditions

None listed

Brief summary

This study is examining if the use of a PET probe during surgery for DCIS or breast cancer can accurately determine if all of the cancer cells have been removed. Currently 20% of patients require a second operation due to potential remaining cancer cells in the breast. Identification of these cells at the time of the first operation may reduce the number of women requiring second operations. This will have an impact on the patient (time & distress) and the health care system.

Interventions

This multidisciplinary one year study will consist of a cohort of 60 patients who have ductal carcinoma in situ (DCIS) or invasive breast cancer, as confirmed by biopsy. Thirty minutes prior to theatre, the patient is injected with 150MBq of f18flurodeoxyglucose (FDG) through a cannula placed in the contra-lateral arm to the breast of interest. Once the specimen has been surgically removed and orientated, the Surgeon will use the beta probe to record counts within the surgical cavity, recordin

This multidisciplinary one year study will consist of a cohort of 60 patients who have ductal carcinoma in situ (DCIS) or invasive breast cancer, as confirmed by biopsy. Thirty minutes prior to theatre, the patient is injected with 150MBq of f18flurodeoxyglucose (FDG) through a cannula placed in the contra-lateral arm to the breast of interest. Once the specimen has been surgically removed and orientated, the Surgeon will use the beta probe to record counts within the surgical cavity, recording the same orientated surfaces as for the excised tissue. The excised tissue will be orientated and the counts recorded for each of the six surfaces (superior, inferior, medial, lateral, superficial, deep) using the beta probe. The gamma probe will then be used over the excised tissue to verify the sample contains FDG positive tissue. In this initial study there would be no action taken on these findings.

Sponsors

Curtin University
Lead SponsorUniversity

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

1. Patient with newly diagnosed DCIS or invasive carcinoma of the breast; 2. Planned to undergo surgical wide local excision; 3. Able to provide informed consent.

Exclusion criteria

1. Planned mastectomy or neoadjuvant therapy; 2. Uncontrolled diabetes mellitus; 3. Pregnant at the time of surgery; 4. Unable to provide informed consent.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026