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

NCT ID: NCT01432002

Last Updated: 2022-12-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-11-30

Study Completion Date

2023-12-31

Brief Summary

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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

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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.

Conditions

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Breast Neoplasm

Keywords

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breast carcinoma FDG PET/CT PET/IRM

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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.
Minimum Eligible Age

19 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Geneva

OTHER

Sponsor Role lead

Responsible Party

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Vincent Vinh-Hung

Privat Docent

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Vincent Vinh-Hung, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Radiation Oncology, Geneva University Hospitals

Locations

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Radiation oncology, Geneva University Hospitals

Geneva, , Switzerland

Site Status

Countries

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Switzerland

References

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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.

Reference Type BACKGROUND
PMID: 18259702 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22777335 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26050658 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 33689151 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 35582655 (View on PubMed)

Other Identifiers

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HUG 07-153

Identifier Type: -

Identifier Source: org_study_id