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
• Status: Active, not recruiting
• 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
• 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.

Related Conditions & MeSH terms

• Breast Neoplasm
• Breast Neoplasms

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