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

• Sponsor: Odense University Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT01552655
• Collaborator: (none)
• Enrollment: 101
• Location: 1
• Arm: 1
• Duration (Months): 36
• Patients Per Site Per Month: 2.8

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Breast Cancer Recurrent	Radiation: Dual-time PET/CT (low-dose)	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 101 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: Single (Investigator)
• Primary Purpose: Diagnostic
• Official Title: Breast Cancer Recurrence - the Accuracy of Dual-time PET/CT
• Study Start Date: Dec 1, 2011
• Actual Primary Completion Date: Dec 1, 2014
• Actual Study Completion Date: Dec 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Other: Dual-time PET/CT	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.

Outcome Measures

Primary Outcome Measures

1. 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

1. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Nuclear Medicine, Odense University Hospital	Odense	Funen	Denmark	5000

Sponsors and Collaborators

• Odense University Hospital

Investigators

• Principal Investigator: Malene Hildebrandt, M.D., Dept. Nuclear Medicine, Odense University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Kirsten Falch, Medical Technologist, Odense University Hospital
• ClinicalTrials.gov Identifier: NCT01552655
• Other Study ID Numbers: BREAC-AUT
• First Posted: Mar 13, 2012
• Last Update Posted: Apr 21, 2015
• Last Verified: Apr 1, 2015

• Keywords provided by Kirsten Falch, Medical Technologist, Odense University Hospital: Dual-time PET/CT; Breast cancer recurrence; Bone scintigraphy; CT thorax upper abdomen
• Additional relevant MeSH terms: Breast Neoplasms; Recurrence

Study Results

No Results Posted as of Apr 21, 2015