NCT02101320

Brief Summary

In France, breast cancer affects approximately 53,000 new cases per year. The investigators have to take care more and more women with subclinical lesions (nonpalpable), and it represents around 25% to 35% of the diagnosed breast cancers. The main problem of the surgical management of these lesions is the quality of preoperative identification which determines the quality of surgery and oncological and cosmetic outcomes. For this type of lesion, SNOLL (Sentinel Node and Occult Lesion Localization) procedure could be proposed. This is a radioactive labeling of the tumor site and sentinel lymph node (SLN). The investigators want to evaluate the potential benefits of using a hand held camera called TreCam in this SNOLL procedure. This camera permits to obtain nuclear imaging at the bedside and in the operating theater.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
47

participants targeted

Target at P25-P50 for not_applicable breast-cancer

Timeline
Completed

Started May 2015

Typical duration for not_applicable breast-cancer

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

February 6, 2014

Completed
2 months until next milestone

First Posted

Study publicly available on registry

April 2, 2014

Completed
1.1 years until next milestone

Study Start

First participant enrolled

May 20, 2015

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 19, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 19, 2018

Completed
Last Updated

July 31, 2019

Status Verified

July 1, 2019

Enrollment Period

3.1 years

First QC Date

February 6, 2014

Last Update Submit

July 29, 2019

Conditions

Breast Cancer

Keywords

surgerynuclear medicineLymphoscintigraphyGamma CameraSNOLLbreast cancer

Outcome Measures

Primary Outcomes (1)

  • Rate of further surgery for non in sano or inadequate (less than 3 mm security margins) lumpectomy piece's margins.

    Between 2 and 3 weeks

Secondary Outcomes (11)

  • Size, volume and weight of the lumpectomy.

    between 2 and 3 weeks

  • Status of resection margins

    one day

  • Cosmetics results: 4 point Score

    between 2 and 3 weeks

  • Morbidity

    between 2 and 3 weeks

  • Volume of resection / tumor volume

    between 2 and 3 weeks

  • +6 more secondary outcomes

Study Arms (2)

Group 1

NO INTERVENTION

Patients with a resection of the lesions according to the procedure SNOLL without the use of TReCam.

Group 2

EXPERIMENTAL

Patients with a resection of the lesions according to the procedure SNOLL with the use of TReCam.

Device: TRECAM

Interventions

TRECAMDEVICE

using the camera during the surgery

Also known as: hand held Camera
Group 2

Eligibility Criteria

Age19 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients older than 18 years
  • Patients undergoing SNOLL procedure for breast non palpable invasive cancer (ultrasound image target) confirmed by biopsy before surgery
  • Clinical T0N0 stage
  • Before the SNOLL procedure, patients will be informed on all this procedure
  • A free and informed consent must be obtained

You may not qualify if:

  • Multifocal breast cancer, diffuse microcalcifications
  • Non-palpable breast cancer without ultrasound target
  • Isolated in situ cancer or invasive cancer associated with extended in situ carcinoma
  • Patients who underwent neoadjuvant chemotherapy
  • Palpable axillary nodes on clinical examination or with a suspicious or positive cytology
  • Pregnant patient
  • History of axillary surgery or mammoplasty
  • Allergy to any component of the tracking technique

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Service de gynécologie-Obstétrie

Bondy, 93140, France

Location

Related Publications (7)

  • Barranger E, Uzan S, Pitre S, Duval MA, Charon Y. [Development of a hand-held gamma camera (POCI) in the sentinel node biopsy for breast cancer]. Pathol Biol (Paris). 2008 Jul;56(5):254-6. doi: 10.1016/j.patbio.2007.09.009. Epub 2008 Feb 21. No abstract available. French.

    PMID: 18178328BACKGROUND

  • Medina-Franco H, Abarca-Perez L, Garcia-Alvarez MN, Ulloa-Gomez JL, Romero-Trejo C, Sepulveda-Mendez J. Radioguided occult lesion localization (ROLL) versus wire-guided lumpectomy for non-palpable breast lesions: a randomized prospective evaluation. J Surg Oncol. 2008 Feb 1;97(2):108-11. doi: 10.1002/jso.20880.

    PMID: 18181162BACKGROUND

  • Lavoue V, Nos C, Clough KB, Baghaie F, Zerbib E, Poulet B, Lefrere Belda MA, Ducellier A, Lecuru F. Simplified technique of radioguided occult lesion localization (ROLL) plus sentinel lymph node biopsy (SNOLL) in breast carcinoma. Ann Surg Oncol. 2008 Sep;15(9):2556-61. doi: 10.1245/s10434-008-9994-y. Epub 2008 Jun 24.

    PMID: 18574635BACKGROUND

  • Monti S, Galimberti V, Trifiro G, De Cicco C, Peradze N, Brenelli F, Fernandez-Rodriguez J, Rotmensz N, Latronico A, Berrettini A, Mauri M, Machado L, Luini A, Paganelli G. Occult breast lesion localization plus sentinel node biopsy (SNOLL): experience with 959 patients at the European Institute of Oncology. Ann Surg Oncol. 2007 Oct;14(10):2928-31. doi: 10.1245/s10434-007-9452-2. Epub 2007 Aug 1.

    PMID: 17674108BACKGROUND

  • Kerrou K, Pitre S, Coutant C, Rouzier R, Ancel PY, Lebeaux C, Huchet V, Montravers F, Pascal O, Duval MA, Lefebvre F, Menard L, Uzan S, Charon Y, Barranger E. The usefulness of a preoperative compact imager, a hand-held gamma-camera for breast cancer sentinel node biopsy: final results of a prospective double-blind, clinical study. J Nucl Med. 2011 Sep;52(9):1346-53. doi: 10.2967/jnumed.111.090464. Epub 2011 Aug 17.

    PMID: 21849400BACKGROUND

  • Bricou A, Duval MA, Charon Y, Barranger E. Mobile gamma cameras in breast cancer care - a review. Eur J Surg Oncol. 2013 May;39(5):409-16. doi: 10.1016/j.ejso.2013.02.008. Epub 2013 Mar 7.

    PMID: 23465183BACKGROUND

  • The Tumor Resection Camera (TReCam), a multipixel imaging probe for radio-guided surgery.E. Netter, L. Pinot, L. Ménard, M.-A. Duval, B. Janvier, F. Lefebvre, R. Siebert, Y. Charon. Nuclear Science Symposium Conference Record (NSS/MIC), 2009 IEEE, 2573-2576

    BACKGROUND

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Alexandre BRICOU, MD

    Hôpital Jean Verdier

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 6, 2014

First Posted

April 2, 2014

Study Start

May 20, 2015

Primary Completion

June 19, 2018

Study Completion

June 19, 2018

Last Updated

July 31, 2019

Record last verified: 2019-07

Locations

FR(1)