Sentinel Lymph Node Identification in Patients With Breast Cancer Using SPECT/CT
Primary Purpose
Early-stage Breast Cancer
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
lymphoscintigraphy
Single Photon Emission Tomography
Sponsored by
About this trial
This is an interventional diagnostic trial for Early-stage Breast Cancer
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Lymphoscintigraphy
Single Photon Emission Tomography
Arm Description
Nuclear Medicine diagnostic device using radioactive material
Nuclear Medicine diagnostic device using fusion technique between SPECT and CT
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03468374
Brief Title
Sentinel Lymph Node Identification in Patients With Breast Cancer Using SPECT/CT
Official Title
Role of Sentinel Lymph Node Identification in Patients With Breast Cancer Using SPECT/CT
Study Type
Interventional
2. Study Status
Record Verification Date
February 2018
Overall Recruitment Status
Unknown status
Study Start Date
July 2018 (Anticipated)
Primary Completion Date
October 2019 (Anticipated)
Study Completion Date
September 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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
Detailed Description
The status of axillary lymph node involvement is the best prognostic factor in patients with early stage breast cancer. In the past; removal of all of the axillary lymph nodes (axillary lymph node dissection, ALND) was often the preferred method of treatment.
ALND, however, has significant short- and long-term morbidity, the most significant being lymphoedema. With the trend towards earlier detection and presentation of breast cancer, most patients do not have lymphatic metastases at diagnosis.
In these patients, ALND is purely a diagnostic procedure, with no therapeutic benefit; besides the widespread use of breast conserving surgery, the staging procedure carries greater morbidity than the therapeutic procedure of the primary cancer.
Sentinel lymph nodes (SLNs) are defined as the first lymph nodes in a tumor bed that receive lymphatic drainage directly from the primary tumor; accordingly these nodes are most likely to harbor metastasizing cancer cells along the path of lymph drainage of tumor tissues, if lymphatic metastasis does occur.
SLN biopsy (SLNB) has been demonstrated to be an ideal option to accurately stage axillary nodal involvement in breast cancer; it is a minimally invasive technique for lymphatic staging. The accurate detection of the SLN is paramount for the success of the procedure.
SLNB in patients with clinically node-negative breast cancer is a valuable procedure for nodal staging ,treatment selection guiding, and often spares patients from the potentially devastating side effects of ALND such as lymphedema while maintaining the curative effect of surgery.
Although being an important element in identification of SLNs; interpretation of planar lymphoscintigraphy is hindered by the absence of anatomical landmarks in the scintigraphic image.
Single photon emission computed tomography coupled with computed tomography (SPECT/CT) was introduced in lymphatic mapping with the goal to show more SLNs and to show them more clearly than is possible with planar lymphoscintigraphy to improve nodal staging.
Besides providing functional scintigraphic information, it provides accurate anatomical localization. This advantage facilitates surgical exploration.
SPECT/CT can detect additional nodes not visualized on planar images and is especially useful in visualization of SLN outside the axilla or nodes close to the injection site.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Early-stage Breast Cancer
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
4 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Lymphoscintigraphy
Arm Type
Active Comparator
Arm Description
Nuclear Medicine diagnostic device using radioactive material
Arm Title
Single Photon Emission Tomography
Arm Type
Active Comparator
Arm Description
Nuclear Medicine diagnostic device using fusion technique between SPECT and CT
Intervention Type
Device
Intervention Name(s)
lymphoscintigraphy
Intervention Description
Nuclear Medicine diagnostic device using radioactive material
Intervention Type
Device
Intervention Name(s)
Single Photon Emission Tomography
Intervention Description
Nuclear Medicine diagnostic device using fusion technique between SPECT and CT
Primary Outcome Measure Information:
Title
Role of SPECT/CT in sentinel lymph node detection in breast cancer
Description
Early detection of sentinel lymph node in patients with breast cancer using SPECT/CT by radioactive material nanocolloid to change surgical approach
Time Frame
3 years
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Raghda Farweiz, Ass lecturer
Phone
01008224401
Email
raghdafarweiz@yahoo.com
First Name & Middle Initial & Last Name or Official Title & Degree
Nadia Mohany, lecturer
Phone
01096117096
Email
drnadia1980@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
18330650
Citation
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.
Results Reference
background
PubMed Identifier
8092905
Citation
Giuliano 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.
Results Reference
background
PubMed Identifier
16329134
Citation
Kim 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.
Results Reference
background
PubMed Identifier
20700739
Citation
Cheng 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.
Results Reference
background
PubMed Identifier
18174216
Citation
Somasundaram 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.
Results Reference
background
PubMed Identifier
19330179
Citation
Sadeghi 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.
Results Reference
background
PubMed Identifier
16617387
Citation
Hubalewska-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.
Results Reference
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Sentinel Lymph Node Identification in Patients With Breast Cancer Using SPECT/CT
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