NCT01552655

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 101 (actual)
• Sponsor: Odense University Hospital · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Breast Cancer Recurrent

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2011-12-01
• Primary completion: 2014-12-01
• Completion: 2014-12-01
• First posted: 2012-03-13
• Last updated: 2015-04-21

Locations

1 site across 1 country: Denmark