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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03468374
Recruitment Status : Not yet recruiting
First Posted : March 16, 2018
Last Update Posted : March 16, 2018
Sponsor:
Information provided by (Responsible Party):
Raghda Hassan Mohamed Farweiz, Assiut University

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

Condition or disease Intervention/treatment Phase
Early-stage Breast Cancer Device: lymphoscintigraphy Device: Single Photon Emission Tomography Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 4 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Role of Sentinel Lymph Node Identification in Patients With Breast Cancer Using SPECT/CT
Estimated Study Start Date : July 2018
Estimated Primary Completion Date : October 2019
Estimated Study Completion Date : September 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
Active Comparator: Lymphoscintigraphy
Nuclear Medicine diagnostic device using radioactive material
Device: lymphoscintigraphy
Nuclear Medicine diagnostic device using radioactive material

Active Comparator: Single Photon Emission Tomography
Nuclear Medicine diagnostic device using fusion technique between SPECT and CT
Device: Single Photon Emission Tomography
Nuclear Medicine diagnostic device using fusion technique between SPECT and CT




Primary Outcome Measures :
  1. Role of SPECT/CT in sentinel lymph node detection in breast cancer [ Time Frame: 3 years ]
    Early detection of sentinel lymph node in patients with breast cancer using SPECT/CT by radioactive material nanocolloid to change surgical approach



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03468374


Contacts
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Contact: Raghda Farweiz, Ass lecturer 01008224401 raghdafarweiz@yahoo.com
Contact: Nadia Mohany, lecturer 01096117096 drnadia1980@gmail.com

Sponsors and Collaborators
Assiut University

Publications:
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Responsible Party: Raghda Hassan Mohamed Farweiz, Assiut Medical School Ethical Review Board, Assiut University
ClinicalTrials.gov Identifier: NCT03468374    
Other Study ID Numbers: SLN SPECT
First Posted: March 16, 2018    Key Record Dates
Last Update Posted: March 16, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases