Head CancerPhase 4SENTINELSEEKNCT04261179
Study Comparing Lymphoseek® vs. Albumin Nanocolloid in Head and Neck, Melanoma and Breast Cancer
A Phase 4 study testing Lymphoseek and Nanocoll in people with Head Cancer and Neck Cancer, run by Anna Cruceta at 1 site in Spain.
Trial summary
Comparison of the concordance of albumin nanocolloid and Lymphoseek® in the detection of lymph nodes of primary and secondary stage drainage by performing two lymphogammagrams Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head Cancer, Neck Cancer, Melanoma
- What is being tested?
- Lymphoseek and Nanocoll
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSpain
- Study dates
- Mar 2020to Aug 2021
- Phase
- Phase 4
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Written informed consent
- Histologically confirmed diagnosis of melanoma, breast cancer or head and neck cancer and candidate for surgical resection with lymph node mapping being a part of the surgical plan.
- At least 18 years of age at the time of consent.
- The subject is clinically node negative (cN0) at the time of screening.
- In Melanoma Patients
- Diagnosis of primary melanoma with sentinel node indication ( >0.8 mm Breslow thickness; clinically negative lymph nodes)
Show all 11Show fewer
- In Breast Cancer Patients
- T1-T2 N0 breast cancer.
- Patients with pure ductal carcinoma in situ (DCIS) if lymph node biopsy is part of the surgical plan.
- In Oral cavity tumors patients
- T1-T2 N0 oral cavity squamous cell carcinoma
Who cannot join
- Pregnancy or lactation
- Clinical or radiological evidence of metastatic cancer including palpably abnormal or enlarged lymph nodes
- Patients that have had preoperative chemotherapy, immunotherapy or radiation therapy
- Patients who have undergone node basin surgery of any type or radiation to the nodal basin(s) potentially draining the primary tumor
- Patients who have undergone a wide excision for their tumor or complex reconstruction (rotation, free flap or skin graft of any type).
Trial locations and contacts
1 site in 1 country.
Spain1 site
Hospital Clínico y provincial de Barcelona
Barcelona, 08036
Anna Cruceta Arboles, MD, acruceta@clinic.ub.es
About this study
Official title: An Exploratory Prospective, Open-label, Unicentric Study With Cross-over Design, Comparing Lymphoseek® vs. Albumin Nanocolloid for Image- Guided Sentinel Lymph Node Mapping in Head and Neck, Melanoma and Breast Cancer.
Comparison of the concordance of albumin nanocolloid and Lymphoseek® in the detection of lymph nodes of primary and secondary stage drainage by performing two lymphogammagrams
- Conditions
- Head Cancer, Neck Cancer, Melanoma, Breast Cancer
- Being tested
- Lymphoseek, Nanocoll
- Medical subject headings
- Head and Neck Neoplasms, Melanoma, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LymphoseekDrug
50 μg microgram(s), timepoint: 30-60 minutes
NanocollDrug
500 μg microgram(s), timepoint: 30-60 minutes
| Study group | Role | What they receive |
|---|---|---|
| Lymphoseek + Nanocoll | Other | Comparison of the concordance of albumin nanocolloid and Lymphoseek® in the detection of lymph nodes of primary and secondary stage drainage by performing two lymphogammagrams Receives: Drug: Lymphoseek; Drug: Nanocoll |
What is being measured
The primary outcome is the main question the study is designed to answer.
Nodal Concordance: proportion of lymph nodes identified by 99mTc-tilmanocept vs nanocolloidal human serum albumin by lymphoscintigraphies
number and diameter in millimeters of nodes affected identified by 99mTc-tilmanocept vs nanocolloidal
Measured: for at least 48 consecutive hours
Secondary outcomes (5)
Time frame to ascertain the sentinel nodes
Measured: 1 week
Concordance among early and delayed images obtained withLymphoseek® or with albumianocolloid and the SPECT/CT images.
Measured: 1 week
Number of sentinel nodes and secondary nodes depicted
Measured: 1 week
Tracer retention in injection site
Measured: 1 week
Safety and tolerability of 99mTctilmanocept (Lymphoseek®)
Number of participants with treatment-related adverse events as assessed by Lymphoseek® or with albuminanocolloid
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2020
- Study startMar 2020 (estimated)
- Primary completionFeb 2021 (estimated)
- Study completionAug 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head 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 4
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Anna Cruceta
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Anna Cruceta, Fundacion Clinic per a la Recerca Biomédica
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04261179
- Sponsor's protocol ID
- 2019-003825-56
- Other IDs
- 2019
- Acronym
- SENTINELSEEK
- Status last verified
- Feb 2020
- First submitted
- 5 Feb 2020
- Last updated
- 20 Feb 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exploratory Prospective, Open-label, Unicentric Study With Cross-over Design, Comparing Lymphoseek® vs. Albumin Nanocolloid for Image- Guided Sentinel Lymph Node Mapping in Head and Neck, Melanoma and Breast Cancer.
- ClinicalTrials.gov ID
- NCT04261179
- Acronym / sponsor ID
- SENTINELSEEK / 2019-003825-56
- Conditions
- Head Cancer, Neck Cancer, Melanoma, Breast Cancer
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Anna CrucetaUniversity, hospital or other
- Study start
- Mar 2020 (estimated)
- Primary completion
- Feb 2021 (estimated)
- Study completion
- Aug 2021 (estimated)
- First posted
- 7 Feb 2020 (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.
Comparison of the concordance of albumin nanocolloid and Lymphoseek® in the detection of lymph nodes of primary and secondary stage drainage by performing two lymphogammagrams
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lymphoseek + Nanocoll | Other | Drug: Lymphoseek, Drug: NanocollComparison of the concordance of albumin nanocolloid and Lymphoseek® in the detection of lymph nodes of primary and secondary stage drainage by performing two lymphogammagrams |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Written informed consent
- Histologically confirmed diagnosis of melanoma, breast cancer or head and neck cancer and candidate for surgical resection with lymph node mapping being a part of the surgical plan.
- At least 18 years of age at the time of consent.
- The subject is clinically node negative (cN0) at the time of screening.
- In Melanoma Patients
Key exclusion criteria (5 listed)
- Pregnancy or lactation
- Clinical or radiological evidence of metastatic cancer including palpably abnormal or enlarged lymph nodes
- Patients that have had preoperative chemotherapy, immunotherapy or radiation therapy
- Patients who have undergone node basin surgery of any type or radiation to the nodal basin(s) potentially draining the primary tumor
- Patients who have undergone a wide excision for their tumor or complex reconstruction (rotation, free flap or skin graft of any type).
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 |
|---|---|---|
| Lymphoseek50 μg microgram(s), timepoint: 30-60 minutes | Drug | Lymphoseek + Nanocoll |
| Nanocoll500 μg microgram(s), timepoint: 30-60 minutes | Drug | Lymphoseek + Nanocoll |
Primary outcome
Nodal Concordance: proportion of lymph nodes identified by 99mTc-tilmanocept vs nanocolloidal human serum albumin by lymphoscintigraphies
Time frame: for at least 48 consecutive hours
number and diameter in millimeters of nodes affected identified by 99mTc-tilmanocept vs nanocolloidal
5 secondary outcomes
Time frame to ascertain the sentinel nodes
Time frame: 1 week
Concordance among early and delayed images obtained withLymphoseek® or with albumianocolloid and the SPECT/CT images.
Time frame: 1 week
Number of sentinel nodes and secondary nodes depicted
Time frame: 1 week
Tracer retention in injection site
Time frame: 1 week
Safety and tolerability of 99mTctilmanocept (Lymphoseek®)
Time frame: 1 week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2020.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Lymphoseek and Nanocoll in people with Head Cancer and Neck Cancer, run by Anna Cruceta 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 11 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 20 Feb 2020. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Nodal Concordance: proportion of lymph nodes identified by 99mTc-tilmanocept vs nanocolloidal human serum albumin by lymphoscintigraphies (time frame: for at least 48 consecutive hours). 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 20 Feb 2020.