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

Not Applicable

Completed

• Conditions: Breast Cancer Recurrent
• Interventions: Radiation: Dual-time PET/CT (low-dose)

• Registration Number: NCT01552655
• Lead Sponsor: Odense University Hospital

Brief 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).

Detailed Description

Not available

Study Timeline

• Study Start: 2011-12
• Study First Submitted: 2012-02-28
• Study First Submitted QC: 2012-03-09
• Study First Posted: 2012-03-13
• Primary Completion: 2014-12
• Study Completion: 2014-12
• Status Verified: 2015-04
• Last Update Submitted: 2015-04-20
• Last Update Posted: 2015-04-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 101

Inclusion Criteria

• Clinical suspected recurrence of breast cancer
• Blood glucose level less than 8,0 mmol/L

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Dual-time PET/CT	Dual-time PET/CT (low-dose)	-

Primary Outcome Measures

Name	Time	Method
Diagnostic value of dual-time point 18FDG PET/CT in recurrent breast cancer	2 years	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.

Secondary Outcome Measures

Name	Time	Method
Diagnostic value of early and late 18FDG PET/CT respectively in recurrent breast cancer	2 years	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.

Trial Locations

Locations (1)

Department of Nuclear Medicine, Odense University Hospital; 🇩🇰 Odense, Funen, Denmark