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
1 other identifier
interventional
4
0 countries
N/A
Brief Summary
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jul 2018
Longer than P75 for not_applicable
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
March 4, 2018
CompletedFirst Posted
Study publicly available on registry
March 16, 2018
CompletedStudy Start
First participant enrolled
July 1, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2022
CompletedMarch 16, 2018
February 1, 2018
1.3 years
March 4, 2018
March 15, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Role of SPECT/CT in sentinel lymph node detection in breast cancer
Early detection of sentinel lymph node in patients with breast cancer using SPECT/CT by radioactive material nanocolloid to change surgical approach
3 years
Study Arms (2)
Lymphoscintigraphy
ACTIVE COMPARATORNuclear Medicine diagnostic device using radioactive material
Single Photon Emission Tomography
ACTIVE COMPARATORNuclear Medicine diagnostic device using fusion technique between SPECT and CT
Interventions
Nuclear Medicine diagnostic device using radioactive material
Nuclear Medicine diagnostic device using fusion technique between SPECT and CT
Eligibility Criteria
You may qualify if:
- 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).
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (7)
Samphao 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: 18330650BACKGROUNDGiuliano 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: 8092905BACKGROUNDKim 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: 16329134BACKGROUNDCheng 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: 20700739BACKGROUNDSomasundaram 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: 18174216BACKGROUNDSadeghi 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: 19330179BACKGROUNDHubalewska-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: 16617387BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assiut Medical School Ethical Review Board
Study Record Dates
First Submitted
March 4, 2018
First Posted
March 16, 2018
Study Start
July 1, 2018
Primary Completion
October 1, 2019
Study Completion
September 1, 2022
Last Updated
March 16, 2018
Record last verified: 2018-02