Breast CancerPhase 3SENTINAC-01NCT02249208
Sentinel Lymph Node Biopsy With Superparamagnetic Iron Oxide for Breast Cancer Patients After Neoadjuvant Treatment.
A Phase 3 study testing Tc+blue dye, Tc+SPIO and SPIO alone in people with Breast Cancer, run by Hospital Universitari Vall d'Hebron Research Institute at 1 site in Spain.
Trial summary
The purpose of this study is to determine the detection rate and the false negative rate of sentinel lymph node (SLN) by superparamagnetic iron oxide (SPIO) alone or in addition to radioisotope and compared to the standard method (blue and radioisotope) after neoadjuvant chemotherapy in patients with node-positive… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Tc+blue dye, Tc+SPIO and SPIO alone
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteSpain
- Study dates
- Apr 2014to Jun 2016
- Phase
- Phase 3
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically proven primary invasive breast cancer with clinical stage T1 through T3, N1 through N2, M0 according to the American Joint Committee on Cancer (AJCC) Cancer Staging Manual, seventh edition
- Completed or were planning to undergo neoadjuvant chemotherapy
- Prechemotherapy axillary nodal disease confirmed by fine-needle aspiration or core-needle biopsy
- The axilla is clinically and radiologically (by ultrasound) negative (ycN0) postchemotherapy and before surgery
- Removal of at least two SLNs
- Signed informed consent from each patient before study entry
Who cannot join
- T4 tumors, cN3 or cM1
- The axilla is clinically and radiologically (by ultrasound) positive (ycN1) postchemotherapy
- Intolerance or hypersensitivity to the compounds or iron dextran or superparamagnetic iron oxide or to vital blue dye or radioactive product.
- Chronic iron overload
- Pacemaker or other metallic implantable device in the chest wall
- Failure to submit to medical study for geographical, social or psychological
- Patient deprived of liberty or under guardianship
- Pregnant or lactating
Trial locations and contacts
1 site in 1 country.
Isabel T Rubio, MD. PhD. contact
Spain1 site, 1 recruiting
- Recruiting
Hospital Universitario Vall D Hebron.
Barcelona, 08035
Isabel T Rubio, MD. PhD.
Martin Espinosa-Bravo, MD. PhD.
About this study
Official title: Sentinel Lymph Node Biopsy With Superparamagnetic Iron Oxide vs. Standard Technique After Neoadjuvant Chemotherapy in Patients With Node-Positive Breast Cancer. A Randomized Controlled Trial.
The purpose of this study is to determine the detection rate and the false negative rate of sentinel lymph node (SLN) by superparamagnetic iron oxide (SPIO) alone or in addition to radioisotope and compared to the standard method (blue and radioisotope) after neoadjuvant chemotherapy in patients with node-positive breast cancer converted to node negative after treatment by ultrasound. A randomized controlled trial.
Read the detailed description
Identification of Sentinel node:
- Arm 1 (Tc+blue dye): Identification of SLN using the standard technique of sub-areolar injection of technetium-99m (Tc-99m) and vital blue dye before surgery.
- Arm 2 (Tc+SPIO): Identification of SLN using standard isotope technique of sub-areolar injection of technetium-99m (Tc-99m) before surgery and the magnetic technique with the sub-areolar injection of SPIO (Sienna+®) before surgery and detection with the SentiMag® probe. (Study)
- Arm 3 (SPIO alone): Identification of SLN using the magnetic technique with the sub-areolar injection of SPIO (Sienna+®) before surgery and detection with the SentiMag® probe. (Study)
Sentinel node's excision of radioactive and / or blue and / or magnetic (colored brown-brown), detection guided by hand probe gamma radiation, colorimetric and / or and SentiMag® paramagnetic probe.
Lymph nodes that are radioactive, blue, magnetic or palpable are considered SLNs and are resected and submitted for pathological analysis. The protocol required that at least 2 SLNs to be resected.
In all cases a completion axillary lymphadenectomy nodes dissection (ALND) will be performed after SLN biopsy. All SLNs will be excised and submitted before performing the ALND.
Characterization of the nodal status of patients with the detection rate and the false negative rate of SLN for each arm.
- Conditions
- Breast Cancer
- Being tested
- Tc+blue dye, Tc+SPIO, SPIO alone
- Keywords
- Breast Cancer, Sentinel Lymph Node, Neoadjuvant Chemotherapy, Clinically Node-Positive with biopsy-proven cN1, False-negative Rate
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tc+blue dyeDevice
Sentinel Lymph Node (SLN) identification and resection using the standard technique of sub-areolar injection of technetium-99m (Tc-99m) and sub-areolar injection of vital blue dye before surgery
Tc+SPIODevice
Sentinel Lymph Node (SLN) identification and resection using isotope technique of sub-areolar injection of technetium-99m (Tc-99m) and the magnetic technique with the sub-areolar injection of SPIO (Sienna+®), before surgery
SPIO aloneDevice
Sentinel Lymph Node (SLN) identification and resection using the magnetic technique with the sub-areolar injection of SPIO (Sienna+®) before surgery
| Study group | Role | What they receive |
|---|---|---|
| Tc+blue dye | Active comparator | Sentinel Lymph Node (SLN) identification and resection using the standard technique of sub-areolar injection of technetium-99m (Tc-99m) and sub-areolar injection of vital blue dye before surgery. Receives: Device: Tc+blue dye |
| Tc+SPIO | Experimental | Sentinel Lymph Node (SLN) identification and resection using isotope technique of sub-areolar injection of technetium-99m (Tc-99m) and the magnetic technique with the sub-areolar injection of SPIO (Sienna+®), before surgery. Receives: Device: Tc+SPIO |
| SPIO alone | Experimental | Sentinel Lymph Node (SLN) identification and resection using the magnetic technique with the sub-areolar injection of SPIO (Sienna+®) before surgery. Receives: Device: SPIO alone |
What is being measured
The primary outcome is the main question the study is designed to answer.
False Negative Rate
The proportion of number of patients with a negative SLN biopsy with the number of patients with axillary lymph node metastases.
Measured: 3 months
Secondary outcomes (1)
Detection Rate
The Proportion of patients that SLNs was identified compared to total ALND patients.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2014 (estimated)
- Study startApr 2014
- Primary completionJun 2016 (estimated)
- Study completionJun 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- 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 3
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Universitari Vall d'Hebron Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Sysmex España S.L.
- Responsible party
- Sponsor
- Investigators
- Isabel T Rubio, MD. PhD., Study director, Hospital Universitario Vall D Hebron. Universidad Autónoma de Barcelona.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02249208
- Sponsor's protocol ID
- SENTINAC-01
- Acronym
- SENTINAC-01
- Status last verified
- Sep 2014
- First submitted
- 18 Sep 2014
- Last updated
- 30 Sep 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sentinel Lymph Node Biopsy With Superparamagnetic Iron Oxide vs. Standard Technique After Neoadjuvant Chemotherapy in Patients With Node-Positive Breast Cancer. A Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT02249208
- Acronym / sponsor ID
- SENTINAC-01 / SENTINAC-01
- Conditions
- Breast Cancer
- Keywords
- Breast Cancer, Sentinel Lymph Node, Neoadjuvant Chemotherapy, Clinically Node-Positive with biopsy-proven cN1, False-negative Rate
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Hospital Universitari Vall d'Hebron Research InstituteUniversity, hospital or other
- Collaborators
- Sysmex España S.L.
- Study start
- Apr 2014
- Primary completion
- Jun 2016 (estimated)
- Study completion
- Jun 2016 (estimated)
- First posted
- 25 Sep 2014 (estimated)
- 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.
The purpose of this study is to determine the detection rate and the false negative rate of sentinel lymph node (SLN) by superparamagnetic iron oxide (SPIO) alone or in addition to radioisotope and compared to the standard method (blue and radioisotope) after neoadjuvant chemotherapy in patients with node-positive breast cancer converted to node negative after treatment by ultrasound. A randomized controlled trial.
Detailed description
Identification of Sentinel node:
- Arm 1 (Tc+blue dye): Identification of SLN using the standard technique of sub-areolar injection of technetium-99m (Tc-99m) and vital blue dye before surgery.
- Arm 2 (Tc+SPIO): Identification of SLN using standard isotope technique of sub-areolar injection of technetium-99m (Tc-99m) before surgery and the magnetic technique with the sub-areolar injection of SPIO (Sienna+®) before surgery and detection with the SentiMag® probe. (Study)
- Arm 3 (SPIO alone): Identification of SLN using the magnetic technique with the sub-areolar injection of SPIO (Sienna+®) before surgery and detection with the SentiMag® probe. (Study)
Sentinel node's excision of radioactive and / or blue and / or magnetic (colored brown-brown), detection guided by hand probe gamma radiation, colorimetric and / or and SentiMag® paramagnetic probe.
Lymph nodes that are radioactive, blue, magnetic or palpable are considered SLNs and are resected and submitted for pathological analysis. The protocol required that at least 2 SLNs to be resected.
In all cases a completion axillary lymphadenectomy nodes dissection (ALND) will be performed after SLN biopsy. All SLNs will be excised and submitted before performing the ALND.
Characterization of the nodal status of patients with the detection rate and the false negative rate of SLN for each arm.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Tc+blue dye | Active comparator | Device: Tc+blue dyeSentinel Lymph Node (SLN) identification and resection using the standard technique of sub-areolar injection of technetium-99m (Tc-99m) and sub-areolar injection of vital blue dye before surgery. |
| Tc+SPIO | Experimental | Device: Tc+SPIOSentinel Lymph Node (SLN) identification and resection using isotope technique of sub-areolar injection of technetium-99m (Tc-99m) and the magnetic technique with the sub-areolar injection of SPIO (Sienna+®), before surgery. |
| SPIO alone | Experimental | Device: SPIO aloneSentinel Lymph Node (SLN) identification and resection using the magnetic technique with the sub-areolar injection of SPIO (Sienna+®) before surgery. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Histologically proven primary invasive breast cancer with clinical stage T1 through T3, N1 through N2, M0 according to the American Joint Committee on Cancer (AJCC) Cancer Staging Manual, seventh edition
- Completed or were planning to undergo neoadjuvant chemotherapy
- Prechemotherapy axillary nodal disease confirmed by fine-needle aspiration or core-needle biopsy
- The axilla is clinically and radiologically (by ultrasound) negative (ycN0) postchemotherapy and before surgery
- Removal of at least two SLNs
Key exclusion criteria (8 listed)
- T4 tumors, cN3 or cM1
- The axilla is clinically and radiologically (by ultrasound) positive (ycN1) postchemotherapy
- Intolerance or hypersensitivity to the compounds or iron dextran or superparamagnetic iron oxide or to vital blue dye or radioactive product.
- Chronic iron overload
- Pacemaker or other metallic implantable device in the chest wall
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 |
|---|---|---|
| Tc+blue dyeSentinel Lymph Node (SLN) identification and resection using the standard technique of sub-areolar injection of technetium-99m (Tc-99m) and sub-areolar injection of vital blue dye before surgery | Device | Tc+blue dye |
| Tc+SPIOSentinel Lymph Node (SLN) identification and resection using isotope technique of sub-areolar injection of technetium-99m (Tc-99m) and the magnetic technique with the sub-areolar injection of SPIO (Sienna+®), before surgery | Device | Tc+SPIO |
| SPIO aloneSentinel Lymph Node (SLN) identification and resection using the magnetic technique with the sub-areolar injection of SPIO (Sienna+®) before surgery | Device | SPIO alone |
Primary outcome
False Negative Rate
Time frame: 3 months
The proportion of number of patients with a negative SLN biopsy with the number of patients with axillary lymph node metastases.
1 secondary outcome
Detection Rate
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2014.
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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.
Isabel T Rubio, MD. PhD. contact
Isabel T Rubio, MD. PhD. study director
Hospital Universitario Vall D Hebron. Universidad Autónoma de Barcelona.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Tc+blue dye, Tc+SPIO and SPIO alone in people with Breast Cancer, run by Hospital Universitari Vall d'Hebron Research Institute at 1 site in Spain.
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 6 inclusion and 8 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 30 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Isabel T Rubio, MD. PhD. (irubio@vhio.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
False Negative Rate (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Sep 2014.