NCT01432002

Brief Summary

The purpose of the study is:

  • to assess the potential benefits of 18F-\[FDG\] PET/CT and PET/MRI for operable breast cancer in order to define the size and location of the primary tumor, as well as axillary, supraclavicular and internal mammary lymph nodes.
  • to apply the imaging results to the simulation and the radiation treatment planning and partial breast for 3-D radiation treatment and partial breast irradiation with intensity modulated radiation treatment (IMRT).

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
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Nov 2007

Longer than P75 for all trials

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

November 1, 2007

Completed
3.8 years until next milestone

First Submitted

Initial submission to the registry

September 2, 2011

Completed
10 days until next milestone

First Posted

Study publicly available on registry

September 12, 2011

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2013

Completed
10.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed
Last Updated

December 21, 2022

Status Verified

December 1, 2022

Enrollment Period

5.5 years

First QC Date

September 2, 2011

Last Update Submit

December 18, 2022

Conditions

Breast Neoplasm

Keywords

breast carcinomaFDGPET/CTPET/IRM

Outcome Measures

Primary Outcomes (1)

  • Drawing of target volumes

    Compare the drawing of target volumes using the PET/CT, PET/IRM information, or without these imaging informations.

    Up to 12 weeks after surgery

Secondary Outcomes (1)

  • Correlate the FDG PET/CT PET/IRM with surgical pathology findings

    Up to 12 weeks after surgery

Eligibility Criteria

Age19 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Women with operable clinically node-negative breast cancer

You may qualify if:

  • Histologically confirmed breast carcinoma
  • Clinical stage T1-2 N0 M0
  • Age \> 18 years
  • Signed informed consent

You may not qualify if:

  • WHO performance index 3
  • Premenopausal women without contraception
  • Gestation
  • Lactating
  • Prior surgery or radiotherapy on the same breast
  • Unable to understand study participation
  • Bilateral breast cancer
  • Prior CT thorax-abdomen and breast MRI within 4 months of interview
  • Presence of electromechanical implant and/or body ferromagnetic material
  • Previous history of renal insufficiency requiring dialysis and/or hospitalisation
  • Ureum and/or creatinine within 2 weeks of interview above lab's reference limits
  • History of contrast allergy
  • Hyperthyroidy
  • Claustrophobia.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Radiation oncology, Geneva University Hospitals

Geneva, 1205, Switzerland

Location

Related Publications (5)

  • Bral S, Vinh-Hung V, Everaert H, De Coninck P, Storme G. The use of molecular imaging to evaluate radiation fields in the adjuvant setting of breast cancer: a feasibility study. Strahlenther Onkol. 2008 Feb;184(2):100-4. doi: 10.1007/s00066-008-1769-7.

    PMID: 18259702BACKGROUND

  • Vinh-Hung V, Everaert H, Lamote J, Voordeckers M, van Parijs H, Vanhoeij M, Verfaillie G, Fontaine C, Vees H, Ratib O, Vlastos G, De Ridder M. Diagnostic and prognostic correlates of preoperative FDG PET for breast cancer. Eur J Nucl Med Mol Imaging. 2012 Oct;39(10):1618-27. doi: 10.1007/s00259-012-2181-1. Epub 2012 Jul 10.

    PMID: 22777335BACKGROUND

  • Tabouret-Viaud C, Botsikas D, Delattre BM, Mainta I, Amzalag G, Rager O, Vinh-Hung V, Miralbell R, Ratib O. PET/MR in Breast Cancer. Semin Nucl Med. 2015 Jul;45(4):304-21. doi: 10.1053/j.semnuclmed.2015.03.003.

    PMID: 26050658BACKGROUND

  • Vinh-Hung V, Everaert H, Gorobets O, Van Parijs H, Verfaillie G, Vanhoeij M, Storme G, Fontaine C, Lamote J, Perrin J, Farid K, Nguyen NP, Verschraegen C, De Ridder M. Breast cancer preoperative 18FDG-PET, overall survival prognostic separation compared with the lymph node ratio. Breast Cancer. 2021 Jul;28(4):956-968. doi: 10.1007/s12282-021-01234-z. Epub 2021 Mar 10.

    PMID: 33689151BACKGROUND

  • Perrin J, Farid K, Van Parijs H, Gorobets O, Vinh-Hung V, Nguyen NP, Djassemi N, De Ridder M, Everaert H. Is there utility for fluorine-18-fluorodeoxyglucose positron-emission tomography scan before surgery in breast cancer? A 15-year overall survival analysis. World J Clin Oncol. 2022 Apr 24;13(4):287-302. doi: 10.5306/wjco.v13.i4.287.

    PMID: 35582655BACKGROUND

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Vincent Vinh-Hung, MD, PhD

    Radiation Oncology, Geneva University Hospitals

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Privat Docent

Study Record Dates

First Submitted

September 2, 2011

First Posted

September 12, 2011

Study Start

November 1, 2007

Primary Completion

May 1, 2013

Study Completion

December 1, 2023

Last Updated

December 21, 2022

Record last verified: 2022-12

Locations

CH(1)