Clinical trial · Interventional

Sentinel Lymph Node Identification in Patients With Breast Cancer Using SPECT/CT

Role of Sentinel Lymph Node Identification in Patients With Breast Cancer Using SPECT/CT

NCT03468374CI-TRIAL-00032109unknownN/AClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

Role of SPECT/CT in detection of sentinel lymph node in patients with breast cancer that is in early stage with small mass with no nodal or distant metastasis using radioactive material nannocolloid that can change surgical approach

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
Early-stage Breast Cancer	Early Stage Breast Carcinoma	ALIAS	0.90

Interventions

Interventions (2)

Intervention	Type	Mapped drug	Match
lymphoscintigraphy	Device	—	UNRESOLVED
Single Photon Emission Tomography	Device	—	UNRESOLVED

Design

Arms and outcomes

Arms (2)

type
ACTIVE_COMPARATOR
label
Lymphoscintigraphy
description
Nuclear Medicine diagnostic device using radioactive material
interventionNames
1. Device: lymphoscintigraphy
type
ACTIVE_COMPARATOR
label
Single Photon Emission Tomography
description
Nuclear Medicine diagnostic device using fusion technique between SPECT and CT
interventionNames
1. Device: Single Photon Emission Tomography

Primary outcomes (1)

measure
Role of SPECT/CT in sentinel lymph node detection in breast cancer
timeFrame
3 years

Eligibility

Eligibility (as posted)

Sex: Female
Minimum age: 18 Years

Show eligibility criteria text

Inclusion Criteria:

* Patients 18≤ years' old, female gender.
* Patients with histopathologically proven breast cancer.
* Patients with early stage and invasive breast cancer stage T1 with mass no more than 2 cm in greatest dimension or stage T2 with mass more than 2 cm but no more than 5 cm in greatest dimension with no clinical evidence of axillary lymph node metastasis(N0) and no remote metastasis (M0).

Exclusion Criteria:

* Patients with LABC, multifocal breast cancer or distant metastasis.
* Clinical, histological or radiological evidence of regional nodal metastasis.
* Prior major breast or axillary operations that could interfere with lymphatic drainage.
* Pregnancy.
* Inability to sign informed consent.

References

Publications (7)

BACKGROUNDSamphao S, Eremin JM, El-Sheemy M, Eremin O. Management of the axilla in women with breast cancer: current clinical practice and a new selective targeted approach. Ann Surg Oncol. 2008 May;15(5):1282-96. doi: 10.1245/s10434-008-9863-8. Epub 2008 Mar 11. PMID 18330650
BACKGROUNDGiuliano AE, Kirgan DM, Guenther JM, Morton DL. Lymphatic mapping and sentinel lymphadenectomy for breast cancer. Ann Surg. 1994 Sep;220(3):391-8; discussion 398-401. doi: 10.1097/00000658-199409000-00015. PMID 8092905
BACKGROUNDKim T, Giuliano AE, Lyman GH. Lymphatic mapping and sentinel lymph node biopsy in early-stage breast carcinoma: a metaanalysis. Cancer. 2006 Jan 1;106(1):4-16. doi: 10.1002/cncr.21568. PMID 16329134
BACKGROUNDCheng G, Kurita S, Torigian DA, Alavi A. Current status of sentinel lymph-node biopsy in patients with breast cancer. Eur J Nucl Med Mol Imaging. 2011 Mar;38(3):562-75. doi: 10.1007/s00259-010-1577-z. Epub 2010 Aug 11. PMID 20700739
BACKGROUNDSomasundaram SK, Chicken DW, Keshtgar MR. Detection of the sentinel lymph node in breast cancer. Br Med Bull. 2007;84:117-31. doi: 10.1093/bmb/ldm032. Epub 2008 Jan 3. PMID 18174216
BACKGROUNDSadeghi R, Forghani MN, Memar B, Abdollahi A, Zakavi SR, Mashhadi MT, Raziee HR, Tavassoli A, Kakhki VR. Comparison of pre-operative lymphoscintigraphy with inter-operative gamma probe and dye technique regarding the number of detected sentinel lymph nodes. Hell J Nucl Med. 2009 Jan-Apr;12(1):30-2. PMID 19330179
BACKGROUNDHubalewska-Dydejczyk A, Sowa-Staszczak A, Huszno B. Current application of sentinel lymph node lymphoscintigraphy to detect various cancer metastases. Hell J Nucl Med. 2006 Jan-Apr;9(1):5-9. PMID 16617387