Breast Cancer Recurrence - the Accuracy of Dual-time PET/CT

Breast Cancer Recurrent Clinical Trial

— BREAC-AUT  

Official title:

Breast Cancer Recurrence - the Accuracy of Dual-time PET/CT

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01552655
• Other study ID #: BREAC-AUT
• Status: Completed
• Phase: N/A
• First received: February 28, 2012
• Last updated: April 20, 2015
• Start date: December 2011
• Est. completion date: December 2014

Study information

• Verified date: April 2015
• Source: Odense University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: The Danish National Committee on Biomedical Research EthicsDenmark: Danish Dataprotection AgencyDenmark: National Board of Health
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to elucidate the value of dual-time-point PET/CT in the recurrence of breast cancer and to determine whether the method is better than the modalities used in the standard work up.

150 patients with suspected breast cancer recurrence will be included. All patients will undergo dual-time-point PET/CT, CT of thorax and upper abdomen and bone scintigraphy. After completion of the examinations the early and the late PET/CT scan will be compared with each other, the diagnostic CT-scan and the bone scintigraphy. A verification of suspicious findings will be done by biopsy, if the area is accessible. If a biopsy cannot be obtained, the presence of recurrence will be verified with additional imaging follow-up to ensure the highest possible confidence. Sensitivity, specificity, accuracy, negative and positive predictive value (NPV/PPV) will be calculated for each modality (incl. early and late PET/CT).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 101
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Clinical suspected recurrence of breast cancer

• Blood glucose level less than 8,0 mmol/L

Exclusion Criteria:

• Disqualified patients

• Other malignancies

• < 18 years

• < 50 kg

• > 90 kg

• Pregnant or lactating

• Patients with permanent address outside of the Region of Southern Denmark

• Estimated inability to collaborate

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Investigator), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Breast Cancer Recurrent
• Breast Neoplasms
• Recurrence

Intervention

Radiation:
• Dual-time PET/CT (low-dose)
4 MBq/kg 18F-flour-deoxyglucose administered iv. PET/CT-scans performed 60 min and 180 min after injection.

Locations

Country	Name	City	State
Denmark	Department of Nuclear Medicine, Odense University Hospital	Odense	Funen

Sponsors (1)

Lead Sponsor	Collaborator
Odense University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diagnostic value of dual-time point 18FDG PET/CT in recurrent breast cancer	The sensitivity and specificity of dual-time point 18FDG PET/CT will be compared to conventional imaging modalities usually used in the work up of patients with suspected recurrent breast cancer. In this case CT of thorax and upper abdomen and bone scintigraphy.	2 years	No
Secondary	Diagnostic value of early and late 18FDG PET/CT respectively in recurrent breast cancer	The sensitivity and specificity of early (60 min post injection) and late (180 min post injection) 18FDG PET/CT respectively in patients with suspected recurrent breast cancer.	2 years	No