Uterine Cervical NeoplasmsPhase 2NCT02509585
A Trial of Comparing the Pathology Status of Lymphoseek®-Identified Sentinel Lymph Nodes Relative to the Pathological Pathology Status of Nonsentinel Lymph Nodes in Nodal Staging of Subjects With Known Cancer of the Cervix Who Are Undergoing Lymph Node Dissection
A Phase 2 study testing Tc99m tilmanocept in people with Uterine Cervical Neoplasms, run by Cardinal Health 414, LLC at 4 sites in United States.
Trial summary
Prospective, open-label, within-patient, multi-center study of Lymphoseek in the detection of lymph nodes in subjects with known cancer of the cervix. All subjects will receive a single dose of 50 µg Lymphoseek radiolabeled with 2 mCi (74 MBq) Tc 99m. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Uterine Cervical Neoplasms
- What is being tested?
- Tc99m tilmanocept
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 4 sitesUnited States
- Study dates
- Jan 2016to Jul 2017
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject has provided written informed consent with HIPAA authorization
- Has cervical cancer and is a candidate for surgical intervention, with lymph node dissection being a part of the surgical plan.
- Is at least 18 years of age at the time of consent
- Has an ECOG performance status of Grade 0 to 2
- Has the following International Federation of Gynecology and Obstetrics (FIGO) IA2-IIA1staging. Subjects with a single enlarged/suspicious node on PET/CT will still be considered eligible as consistent with FIGO guidelines.
- If of childbearing potential, the subject has a negative pregnancy test within 48 hours before administration of Lymphoseek, has been surgically sterilized, or has been postmenopausal for at least 1 year
Who cannot join
- The subject has had preoperative chemotherapy, immunotherapy, or radiation therapy within the 30 days prior to Lymphoseek administration
- Has had previous surgery or radiation to node basins that would be involved in the ILM procedure
- Has a known allergy to dextran
- Is breast-feeding or pregnant
- Before the administration of Lymphoseek, has received any radiopharmaceutical within 7 radioactive half-lives of that radiopharmaceutical
- Is scheduled for surgery and/or another invasive procedure other than the primary surgical intervention within the 3 days after Lymphoseek administration
- Has received an investigational product within the 30 days prior to Lymphoseek administration
Trial locations and contacts
4 sites in 1 country.
United States4 sites
The University of Texas M.D. Anderson Cancer Center
Houston, Texas, 77030
University of California, San Diego
La Jolla, California, 92093
Sylvester Comprehensive Cancer Center
Miami, Florida, 33136
Wake Forest Baptist Health
Winston-Salem, North Carolina, 27157
About this study
Official title: A Prospective, Open-Label Trial of Comparing the Pathology Status of Lymphoseek®-Identified Sentinel Lymph Nodes Relative to the Pathological Pathology Status of Nonsentinel Lymph Nodes in Nodal Staging of Subjects With Known Cancer of the Cervix Who Are Undergoing Lymph Node Dissection
Prospective, open-label, within-patient, multi-center study of Lymphoseek in the detection of lymph nodes in subjects with known cancer of the cervix. All subjects will receive a single dose of 50 µg Lymphoseek radiolabeled with 2 mCi (74 MBq) Tc 99m.
- Conditions
- Uterine Cervical Neoplasms
- Being tested
- Tc99m tilmanocept
- Medical subject headings
- Uterine Cervical Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tc99m tilmanoceptDrug
Also called Lymphoseek
A single dose of 2 mCi (74 MBq) and 50 ug of Tc99m tilmanocept administered peritumorally no more than 20 hours before surgery
| Study group | Role | What they receive |
|---|---|---|
| Tc99m tilmanocept | Experimental | 2 mCi (74 MBq), 50 ug of Tc99M tilmanocept single administration Receives: Drug: Tc99m tilmanocept |
What is being measured
The primary outcome is the main question the study is designed to answer.
Per-subject False Negative Rate
Proportion of subjects with pathologically negative Lymphoseek-identified SLNs and at least one pathologically positive non-SLN
Measured: 1 day
Secondary outcomes (9)
Per-subject Sensitivity
Proportion of subjects with at least one pathologically positive Lymphoseek-identified SLN that have at least one pathologically positive lymph node
Measured: 1 day
Per-subject Negative Predictive Value
Proportion of subjects with pathologically negative Lymphoseek-identified SLN(s) with no pathologically positive lymph nodes
Measured: 1 day
Per-subject Accuracy
Proportion of subjects accurately indentified by Lymphoseek
Measured: 1 day
Proportion of Lymph Nodes Identified Intraoperatively by a Dye That Are Also Identified by Lymphoseek
Measured: 1 day
Number of Lymph Nodes Per-subject Identified by Lymphoseek
Measured: 1 day
Number of Lymph Nodes Per-subject Identified by Other Dyes
Measured: 1 day
Per-subject Concordance
Subjects whose lymph nodes were determined to be dye positive that were also identified by Lymphoseek
Measured: 1 day
Per-subject Reverse Concordance
Number of subjects whose lymph nodes that were identified by Lymphoseek were also all identified by dye
Measured: 1 day
Incidence of Adverse Events
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2015 (estimated)
- Study startJan 2016
- Primary completionJul 2017
- Study completionJul 2017
Why it stopped: low accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Uterine Cervical NeoplasmsStudies 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 2
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cardinal Health 414, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Michael Blue, MD, Study director, Cardinal Health 414, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02509585
- Sponsor's protocol ID
- NAV3-19
- Status last verified
- Feb 2019
- First submitted
- 24 Jul 2015
- Last updated
- 11 Feb 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Open-Label Trial of Comparing the Pathology Status of Lymphoseek®-Identified Sentinel Lymph Nodes Relative to the Pathological Pathology Status of Nonsentinel Lymph Nodes in Nodal Staging of Subjects With Known Cancer of the Cervix Who Are Undergoing Lymph Node Dissection
- ClinicalTrials.gov ID
- NCT02509585
- Acronym / sponsor ID
- NAV3-19
- Conditions
- Uterine Cervical Neoplasms
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: low accrual
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Cardinal Health 414, LLCIndustry (pharma, biotech, devices)
- Study start
- Jan 2016
- Primary completion
- Jul 2017 (actual)
- Study completion
- Jul 2017 (actual)
- First posted
- 28 Jul 2015 (estimated)
- Results
- Posted 11 Feb 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Prospective, open-label, within-patient, multi-center study of Lymphoseek in the detection of lymph nodes in subjects with known cancer of the cervix. All subjects will receive a single dose of 50 µg Lymphoseek radiolabeled with 2 mCi (74 MBq) Tc 99m.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tc99m tilmanocept | Experimental | Drug: Tc99m tilmanocept2 mCi (74 MBq), 50 ug of Tc99M tilmanocept single administration |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Subject has provided written informed consent with HIPAA authorization
- Has cervical cancer and is a candidate for surgical intervention, with lymph node dissection being a part of the surgical plan.
- Is at least 18 years of age at the time of consent
- Has an ECOG performance status of Grade 0 to 2
- Has the following International Federation of Gynecology and Obstetrics (FIGO) IA2-IIA1staging. Subjects with a single enlarged/suspicious node on PET/CT will still be considered eligible as consistent with FIGO guidelines.
Key exclusion criteria (7 listed)
- The subject has had preoperative chemotherapy, immunotherapy, or radiation therapy within the 30 days prior to Lymphoseek administration
- Has had previous surgery or radiation to node basins that would be involved in the ILM procedure
- Has a known allergy to dextran
- Is breast-feeding or pregnant
- Before the administration of Lymphoseek, has received any radiopharmaceutical within 7 radioactive half-lives of that radiopharmaceutical
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 |
|---|---|---|
| Tc99m tilmanoceptAlso: LymphoseekA single dose of 2 mCi (74 MBq) and 50 ug of Tc99m tilmanocept administered peritumorally no more than 20 hours before surgery | Drug | Tc99m tilmanocept |
Primary outcome
Per-subject False Negative Rate
Time frame: 1 day
Proportion of subjects with pathologically negative Lymphoseek-identified SLNs and at least one pathologically positive non-SLN
9 secondary outcomes
Per-subject Sensitivity
Time frame: 1 day
Per-subject Negative Predictive Value
Time frame: 1 day
Per-subject Accuracy
Time frame: 1 day
Proportion of Lymph Nodes Identified Intraoperatively by a Dye That Are Also Identified by Lymphoseek
Time frame: 1 day
Number of Lymph Nodes Per-subject Identified by Lymphoseek
Time frame: 1 day
Number of Lymph Nodes Per-subject Identified by Other Dyes
Time frame: 1 day
Per-subject Concordance
Time frame: 1 day
Per-subject Reverse Concordance
Time frame: 1 day
Incidence of Adverse Events
Time frame: 7 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Michael Blue, MD study director
Cardinal Health 414, LLC
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Tc99m tilmanocept in people with Uterine Cervical Neoplasms, run by Cardinal Health 414, LLC at 4 sites in United States.
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 7 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: stopped early, as of the sponsor's last update on 11 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 Feb 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Per-subject False Negative Rate (time frame: 1 day). 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 11 Feb 2019.