Clinical trial NCT01432002: FDG-PET/CT for Simulation and Radiation Treatment Planning of Early Breast Cancer
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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Breast Neoplasm
Keywords: breast carcinoma
FDG
PET/CT
PET/IRM
Lead sponsor: University Hospital, Geneva
Sponsor class: OTHER
First posted: 2011-09-12
Enrollment: 60
Sex: FEMALE
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women with operable clinically node-negative breast cancer

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).

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Drawing of target volumes
timeFrame: Up to 12 weeks after surgery
Secondary outcomes:
measure: Correlate the FDG PET/CT PET/IRM with surgical pathology findings
timeFrame: Up to 12 weeks after surgery
Other outcomes:
Locations:
city: Geneva
country: Switzerland
facility: Radiation oncology, Geneva University Hospitals
Study officials:
affiliation: Radiation Oncology, Geneva University Hospitals
name: Vincent Vinh-Hung, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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.
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.
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.
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.