Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Proton MR Spectroscopy and 18F-Fluorocholine PET for Breast Cancer Diagnosis

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by National Taiwan University Hospital
Sponsor:
Information provided by (Responsible Party):
National Taiwan University Hospital
ClinicalTrials.gov Identifier:
NCT01956409
First received: September 25, 2013
Last updated: April 11, 2014
Last verified: April 2014

September 25, 2013
April 11, 2014
September 2012
December 2016   (final data collection date for primary outcome measure)
diagnostic accuracy of 18F-FCH PET for breast cancer diagnosis [ Time Frame: 5 years ] [ Designated as safety issue: No ]
The investigators use the interpretation results of 18F-FCH PET for breast lesion diagnosis, with the pathology result of the breast lesions as gold standards, and to investigate how well the 18F-FCH PET can correctly diagnose the true nature of breast lesions.
Same as current
Complete list of historical versions of study NCT01956409 on ClinicalTrials.gov Archive Site
  • Monitoring of treatment response of breast cancer to chemotherapy using 18F-FCH PET [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    For the breast cancer patients who will undergo chemotherapy treatment, we aim to use 18F-FCH PET before and after chemotherapy. And the changes of tracer uptake of 18F-FCH on PET scans before and after chemotherapy will be correlated with clinical outcomes before and after chemotherapy, to investigate whether 18F-FCH PET results can monitor treatment response of chemotherapy.
  • diagnostic accuracy of breast MR spectroscopy for breast cancer diagnosis [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    The investigators use the interpretation results of breast MRI (with MR spectroscopy in the examination) for breast lesion diagnosis, with the pathology result of the breast lesions as gold standards, and to investigate how well the breast MRI study can correctly diagnose the true nature of breast lesions.
Same as current
Evaluation the correlation of 18F-FCH PET and breast MRI [ Time Frame: 5 years ] [ Designated as safety issue: No ]
Same as current
 
Proton MR Spectroscopy and 18F-Fluorocholine PET for Breast Cancer Diagnosis
Use of Proton MR Spectroscopy and 18F-Fluorocholine PET for Breast Cancer Diagnosis, Prediction of Clinical Outcome and Monitoring of Treatment Response to Neoadjuvant Chemotherapy

The application of FCH PET in breast cancer diagnosis has not been reported.

We hypothesize that FCH reveals choline metabolic profiles of breast cancers, and shows the similar pathophysiological mechanism to choline on proton MRS, and our study goals are:

  1. To investigate and compare the diagnostic performance of proton MRS and FCH PET for localized findings on mammography and breast ultrasound.
  2. To investigate whether FCH PET findings are correlated with choline signals on proton MRS.
  3. To evaluate if choline, water and lipid signals on proton MRS, FCH PET are associated with factors related to clinical outcome and prognosis- that is, molecular markers, tumor staging, histologic grade of breast cancers.
  4. For localized advanced breast cancer, to investigate the treatment response to NAC using proton MRS and FCH PET, and to evaluate which modality is more sensitive.
  5. To investigate the usefulness of FCH PET for whole body staging for breast cancer patients.

In recent years, the application of 18F-FDG PET (positron emission tomography) and MRI for breast lesion diagnosis was emerging. Imbriaco et al compared the diagnostic performance of 18F-FDG PET and MRI for suspicious breast lesions, with PET showing a sensitivity of 80% and specificity 100%; and MRI revealed a sensitivity of 95% and specificity of 98%. Lim et al studied 18F-FDG PET-CT with MRI to monitor treatment response for breast cancer patients receiving NAC, with a sensitivity 70% and specificity 72%, and can detect the treatment response earlier than conventional imaging.

However, 18F-FDG is not tumor specific, and searching for an alternative tracer agent as a tumor biomarker is necessary. 18F-Fluorocholine (FCH), a choline analog, was used for diagnosis of prostate cancer, hepatocellular carcinoma (HCC), bronchioloalveolar carcinoma, brain tumor, since malignant tumors show higher choline metabolites than benign lesions; it was reported that FCH PET showed higher sensitivity (88-94%) than 18F-FDG PET (59-68%) in detecting HCC. FCH PET was used for staging for prostate cancer, with FCH PET-CT can provide sufficient information for management with an accuracy of 88%.

Interventional
Phase 4
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
  • Breast Cancer Diagnosis
  • Positron Emission Tomography
  • Magnetic Resonance Imaging
  • Drug: 18F-FCH
    Other Name: N,N-Dimethyl-N-Fluoromethylethanolamine
  • Drug: Magnevist
    Other Name: Gadopentetate dimeglumine
Experimental: diagnostic accuracy of PET and MR spectroscopy
To investigate the diagnostic accuracy of 18F-Fluorocholine PET and proton MR spectroscopy of breast lesions, using pathology as gold standard.
Interventions:
  • Drug: 18F-FCH
  • Drug: Magnevist
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
80
March 2017
December 2016   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Women aged 20-75 years old.
  • with localized findings on mammography or breast ultrasound in recent 3 months and who will receive breast biopsy or excision for the findings; or with recently diagnosed LABC who will receive NAC.

Exclusion Criteria:

  • unable to cooperate with the examinations
  • pregnant or planning to be pregnant
  • estimated GFR (eGFR) < 60 ml/min/1.73m2 or with recent acute renal failure, past history of renal dialysis.
  • Past history of claustrophobia
  • Past history of anaphylactoid reactions to MRI contrast agents or PET tracer agents.
  • with cardiac pacemaker, aneurysmal clip, mechanical valve replacement, recently applied coronary artery stent (<2 months).
  • Past history of breast cancer or other malignancy (treated within 5 years).
  • lactating.
Female
20 Years to 75 Years
No
Contact: Jane Wang, PhD 886223123456 ext 65565 hstjen@yahoo.com.tw
Taiwan
 
NCT01956409
201201056MIB
No
National Taiwan University Hospital
National Taiwan University Hospital
Not Provided
Principal Investigator: Jane Wang, PhD National Taiwan University Hospital
National Taiwan University Hospital
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP