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NCT01432002 Clinical Trial

FDG-PET/CT for Simulation and Radiation Treatment Planning of Early Breast Cancer

Breast Neoplasm Clinical Trial

Official title:
Application of 18F-[FDG] PET/CT to Simulation and Planning of Radiotherapy (RT) for Breast Cancer. Definition of Target Volume for 3-D RT and for Partial Breast Irradiation (PBI) by IMRT Technique

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT01432002
Other study ID # HUG 07-153
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date November 2007
Est. completion date December 2023

Study information
Verified date December 2022
Source University Hospital, Geneva
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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).

Description:

Pre-operative FDG PET/CT, and in option PET/IRM, are intended for women with histologically confirmed operable clinically node-negative breast cancer, in whom breast conserving and post-operative radiotherapy are planned.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 60
Est. completion date December 2023
Est. primary completion date May 2013
Accepts healthy volunteers No
Gender Female
Age group 19 Years and older
Eligibility Inclusion Criteria: - Histologically confirmed breast carcinoma - Clinical stage T1-2 N0 M0 - Age > 18 years - Signed informed consent Exclusion Criteria: - 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.

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Switzerland Radiation oncology, Geneva University Hospitals Geneva

Sponsors (1)
Lead Sponsor Collaborator
University Hospital, Geneva

Country where clinical trial is conducted

Switzerland, 

References & 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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary 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 Correlate the FDG PET/CT PET/IRM with surgical pathology findings Compare the pre-operative imaging information with histopathological description of the resected primary tumor, and with the extent of lymph node involvement. Up to 12 weeks after surgery
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