Clinical trial · Interventional
Hand-held Gamma Camera in the SNOLL Procedure
Contribution of a Hand-held Gamma Camera (TreCam) to the SNOLL(Occult Breast Lesion Localization Plus Sentinel Node Biopsy) Procedure in Breast Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| TRECAM | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- NO_INTERVENTION
- label
- Group 1
- description
- Patients with a resection of the lesions according to the procedure SNOLL without the use of TReCam.
- type
- EXPERIMENTAL
- label
- Group 2
- description
- Patients with a resection of the lesions according to the procedure SNOLL with the use of TReCam.
- interventionNames
- Device: TRECAM
Primary outcomes (1)
- measure
- Rate of further surgery for non in sano or inadequate (less than 3 mm security margins) lumpectomy piece's margins.
- timeFrame
- Between 2 and 3 weeks
Secondary outcomes (11)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 19 Years
Show eligibility criteria text
Inclusion Criteria : * 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 Exclusion Criteria : * 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
References
Publications (7)
- BACKGROUNDBarranger 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 18178328
- BACKGROUNDMedina-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 18181162
- BACKGROUNDLavoue 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 18574635
- BACKGROUNDMonti 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 17674108
- BACKGROUNDKerrou 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 21849400
- BACKGROUNDBricou 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.