Breast Cancer Recurrence - the Accuracy of Dual-time PET/CT (BREAC-AUT)

Odense University Hospital

Status: Completed

Conditions: Breast Cancer Recurrent

Treatments: Radiation: Dual-time PET/CT (low-dose)

Study type: Interventional

Funder types: Other

Identifiers

NCT01552655

BREAC-AUT

Details and patient eligibility

About

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).

Enrollment: 101 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: Single Blind

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101 participants in 1 patient group

Dual-time PET/CT

Other group

Treatment:

Radiation: Dual-time PET/CT (low-dose)