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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

101 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-12-31

Study Completion Date

2014-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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).

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Use of Bone Scintigraphy, CT and MRI in Breast Cancer

NCT00682253

Breast Neoplasms

UNKNOWN

National Screening in Denmark With MR Versus Mammography and Ultrasound of Women With BRCA1 or BRCA2 Mutations

NCT00413491

Breast Cancer

UNKNOWN PHASE4

HER2 PET Imaging in Breast Cancer Patients Using [68GA]ABY-025

NCT02095210

HER2-positive Breast Cancer

TERMINATED PHASE1

Screening MRI for Cancer Recurrence in Patients Treated With Breast Conserving Therapy

NCT01257152

Breast Neoplasms Neoplasm Recurrence, Local

COMPLETED

Diffusion Weighted MRI for Lymphnodes in the Axilla

NCT00276211

Breast Cancer

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Breast Cancer Recurrent

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Dual-time PET/CT

Group Type OTHER

Dual-time PET/CT (low-dose)

Intervention Type RADIATION

4 MBq/kg 18F-flour-deoxyglucose administered iv. PET/CT-scans performed 60 min and 180 min after injection.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type RADIATION

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No