Early-stage Breast CancerNCT03468374
Sentinel Lymph Node Identification in Patients With Breast Cancer Using SPECT/CT
A study testing lymphoscintigraphy and Single Photon Emission Tomography in people with Early-stage Breast Cancer, run by Assiut University.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Early-stage Breast Cancer
- What is being tested?
- lymphoscintigraphy and Single Photon Emission Tomography
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- No sites listed yet
- Study dates
- Jul 2018to Sep 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Role of Sentinel Lymph Node Identification in Patients With Breast Cancer Using SPECT/CT
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
Read the 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.
- Conditions
- Early-stage Breast Cancer
- Being tested
- lymphoscintigraphy, Single Photon Emission Tomography
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lymphoscintigraphyDevice
Nuclear Medicine diagnostic device using radioactive material
Single Photon Emission TomographyDevice
Nuclear Medicine diagnostic device using fusion technique between SPECT and CT
| Study group | Role | What they receive |
|---|---|---|
| Lymphoscintigraphy | Active comparator | Nuclear Medicine diagnostic device using radioactive material Receives: Device: lymphoscintigraphy |
| Single Photon Emission Tomography | Active comparator | Nuclear Medicine diagnostic device using fusion technique between SPECT and CT Receives: Device: Single Photon Emission Tomography |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2018
- Study startJul 2018 (estimated)
- Primary completionOct 2019 (estimated)
- Study completionSep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Early-stage Breast CancerStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 4 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Raghda Hassan Mohamed Farweiz, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03468374
- Sponsor's protocol ID
- SLN SPECT
- Status last verified
- Feb 2018
- First submitted
- 4 Mar 2018
- Last updated
- 16 Mar 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 18330650Giuliano 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.
PubMed 8092905Kim 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.
PubMed 16329134Cheng 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.
PubMed 20700739Somasundaram 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.
PubMed 18174216Sadeghi 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.
PubMed 19330179Hubalewska-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.
PubMed 16617387
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Sentinel Lymph Node Identification in Patients With Breast Cancer Using SPECT/CT
- ClinicalTrials.gov ID
- NCT03468374
- Acronym / sponsor ID
- SLN SPECT
- Conditions
- Early-stage Breast Cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 4 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Jul 2018 (estimated)
- Primary completion
- Oct 2019 (estimated)
- Study completion
- Sep 2022 (estimated)
- First posted
- 16 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lymphoscintigraphy | Active comparator | Device: lymphoscintigraphyNuclear Medicine diagnostic device using radioactive material |
| Single Photon Emission Tomography | Active comparator | Device: Single Photon Emission TomographyNuclear Medicine diagnostic device using fusion technique between SPECT and CT |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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).
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| lymphoscintigraphyNuclear Medicine diagnostic device using radioactive material | Device | Lymphoscintigraphy |
| Single Photon Emission TomographyNuclear Medicine diagnostic device using fusion technique between SPECT and CT | Device | Single Photon Emission Tomography |
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2018.
- Background: PubMed 18330650Samphao 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.
- Background: PubMed 8092905Giuliano 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.
- Background: PubMed 16329134Kim 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.
- Background: PubMed 20700739Cheng 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.
- Background: PubMed 18174216Somasundaram 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.
- Background: PubMed 19330179Sadeghi 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.
- Background: PubMed 16617387Hubalewska-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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing lymphoscintigraphy and Single Photon Emission Tomography in people with Early-stage Breast Cancer, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Raghda Farweiz, Ass lecturer (01008224401, raghdafarweiz@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Role of SPECT/CT in sentinel lymph node detection in breast cancer (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03468374, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2018.