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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
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Early-stage Breast Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

    First Posted
    March 4, 2018
    Last Updated
    March 15, 2018
    Sponsor
    Assiut University
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    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
    background

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

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