NCT00184210

Brief Summary

Breast cancer tissue is collected from women undergoing scheduled surgery for breast cancer. The tissue specimen are analyzed by MR spectroscopy. After MR, the intact tissue specimen can be analyzed by other methods, such as histopathology. The MR spectral profiles are compared to clinical findings such as the patients diagnosis, lymph node status and tumor size.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2000

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
terminated

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

January 1, 2000

Completed
5.7 years until next milestone

First Submitted

Initial submission to the registry

September 12, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 16, 2005

Completed
15.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
Last Updated

March 22, 2021

Status Verified

March 1, 2021

Enrollment Period

20.9 years

First QC Date

September 12, 2005

Last Update Submit

March 18, 2021

Conditions

Keywords

Magnetic Resonance Spectroscopy

Outcome Measures

Primary Outcomes (1)

  • MRimage of breast cancer tissue

    0 hour

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

women in surgery for breast cancer

You may qualify if:

  • Palpable breast cancer lesion

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Norwegian University of Technology and Science

Trondheim, 7491, Norway

Location

Related Publications (5)

  • Sitter B, Sonnewald U, Spraul M, Fjosne HE, Gribbestad IS. High-resolution magic angle spinning MRS of breast cancer tissue. NMR Biomed. 2002 Aug;15(5):327-37. doi: 10.1002/nbm.775.

  • Sitter B, Lundgren S, Bathen TF, Halgunset J, Fjosne HE, Gribbestad IS. Comparison of HR MAS MR spectroscopic profiles of breast cancer tissue with clinical parameters. NMR Biomed. 2006 Feb;19(1):30-40. doi: 10.1002/nbm.992.

  • Bathen TF, Jensen LR, Sitter B, Fjosne HE, Halgunset J, Axelson DE, Gribbestad IS, Lundgren S. MR-determined metabolic phenotype of breast cancer in prediction of lymphatic spread, grade, and hormone status. Breast Cancer Res Treat. 2007 Aug;104(2):181-9. doi: 10.1007/s10549-006-9400-z. Epub 2006 Oct 24.

  • Sitter B, Bathen TF, Singstad TE, Fjosne HE, Lundgren S, Halgunset J, Gribbestad IS. Quantification of metabolites in breast cancer patients with different clinical prognosis using HR MAS MR spectroscopy. NMR Biomed. 2010 May;23(4):424-31. doi: 10.1002/nbm.1478. Epub 2010 Jan 25.

  • Giskeodegard GF, Grinde MT, Sitter B, Axelson DE, Lundgren S, Fjosne HE, Dahl S, Gribbestad IS, Bathen TF. Multivariate modeling and prediction of breast cancer prognostic factors using MR metabolomics. J Proteome Res. 2010 Feb 5;9(2):972-9. doi: 10.1021/pr9008783.

Biospecimen

Retention: SAMPLES WITH DNA

tissue

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Tone F Bathen, PhD

    Norwegian University of Technology and Science

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 16, 2005

Study Start

January 1, 2000

Primary Completion

December 1, 2020

Study Completion

December 1, 2020

Last Updated

March 22, 2021

Record last verified: 2021-03

Locations