NCT01956409

Brief Summary

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. 1.To investigate and compare the diagnostic performance of proton MRS and FCH PET for localized findings on mammography and breast ultrasound.
  2. 2.To investigate whether FCH PET findings are correlated with choline signals on proton MRS.
  3. 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. 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. 5.To investigate the usefulness of FCH PET for whole body staging for breast cancer patients.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Sep 2012

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2012

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

September 25, 2013

Completed
13 days until next milestone

First Posted

Study publicly available on registry

October 8, 2013

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2017

Completed
Last Updated

February 4, 2016

Status Verified

February 1, 2016

Enrollment Period

4.3 years

First QC Date

September 25, 2013

Last Update Submit

February 3, 2016

Conditions

Breast Cancer DiagnosisPositron Emission TomographyMagnetic Resonance Imaging

Keywords

breast neoplasms18F-FCH PETMRI

Outcome Measures

Primary Outcomes (1)

  • diagnostic accuracy of 18F-FCH PET for breast cancer diagnosis

    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.

    5 years

Secondary Outcomes (2)

  • Monitoring of treatment response of breast cancer to chemotherapy using 18F-FCH PET

    5 years

  • diagnostic accuracy of breast MR spectroscopy for breast cancer diagnosis

    5 years

Other Outcomes (1)

  • Evaluation the correlation of 18F-FCH PET and breast MRI

    5 years

Study Arms (1)

diagnostic accuracy of PET and MR spectroscopy

EXPERIMENTAL

To investigate the diagnostic accuracy of 18F-Fluorocholine PET and proton MR spectroscopy of breast lesions, using pathology as gold standard.

Drug: 18F-FCHDrug: Magnevist

Interventions

18F-FCHDRUG
Also known as: N,N-Dimethyl-N-Fluoromethylethanolamine
diagnostic accuracy of PET and MR spectroscopy
MagnevistDRUG
Also known as: Gadopentetate dimeglumine
diagnostic accuracy of PET and MR spectroscopy

Eligibility Criteria

Age20 Years - 75 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University Hospital

Taipei, Taiwan, 100, Taiwan

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

fluorocholineGadolinium DTPA

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Pentetic AcidPolyaminesAminesOrganic ChemicalsAcetatesAcids, AcyclicCarboxylic AcidsCoordination Complexes

Study Officials

  • Jane Wang, PhD

    National Taiwan University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 25, 2013

First Posted

October 8, 2013

Study Start

September 1, 2012

Primary Completion

December 1, 2016

Study Completion

March 1, 2017

Last Updated

February 4, 2016

Record last verified: 2016-02

Locations

TW(1)