AzTrials
AzTrials

Head and Neck Squamous Cell Carcinoma (HNSCC)Phase 3NCT00911326

Evaluation of Sentinel Lymph Nodes in Head and Neck Squamous Cell Carcinoma

A Phase 3 study testing Lymphoseek in people with Head and Neck Squamous Cell Carcinoma (HNSCC), run by Navidea Biopharmaceuticals at 13 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

Trial summary

The purpose of this study is to determine the false negative rate (FNR) associated with Lymphoseek-identified sentinel lymph nodes (SLNs) relative to the pathological status of non-sentinel lymph nodes in elective neck dissection (END) in head \& neck squamous cell carcinoma (HNSCC). Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Lymphoseek
Type of treatment
Injection or infusion
How many people
101 participants
Where
13 sitesUnited States
Study dates
May 2009to Aug 2013
Phase
Phase 3
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
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Subjects meeting all of the following inclusion criteria by the end of the screening phase should be considered for admission to the study:
  • The patient has provided written informed consent with Health Insurance Portability and Accountability Act (HIPAA) authorization before participating in the study.
  • The patient has a diagnosis of primary squamous cell carcinoma of the head and neck either cutaneous or intra-oral that is anatomically located in: mucosal lip, buccal mucosa, lower alveolar ridge, upper alveolar ridge, retromolar gingiva (retromolar trigone), floor of the mouth, hard palette or oral (mobile) tongue, stage T1-T4a, N0, M0.
  • Clinical nodal staging (N0) has been confirmed by negative results from contrast CT scan or gadolinium-enhanced MRI or lateral and central neck ultrasound. PET scan cannot be used for this evaluation.
  • Imaging of the regional nodal basin has been performed within 30 days of the planned lymphadenectomy.
  • The patient is a candidate for surgical intervention, with intraoperative lymphatic mapping and END included in the surgical plan.
Show all 11Show fewer
  • Patients with prior malignancy are allowed provided the patient meets the following criteria:
  • Underwent potentially curative therapy for all prior malignancies and is deemed low risk for recurrence; AND No malignancy for the past 5 years (except effectively treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix effectively treated with surgery alone, lobular carcinoma in situ of the ipsilateral or contralateral breast treated with surgery alone, or carcinoma of the mouth that is in situ or minimally invasive) and no evidence of recurrence.
  • The patient is at least 18 years of age at the time of consent.
  • The patient has an Eastern Cooperative Oncology Group (ECOG) status of Grade 0 - 2.
  • If the patient is a female, the patient has a confirmed negative pregnancy test within 72 hours priors to administration of Lymphoseek, OR has documentation of surgical sterilization, OR has documented evidence of postmenopausal status for at least 1 year.

Who cannot join

  • Patients meeting any of the following exclusion criteria at the end of the screening phase will not be enrolled in the study:
  • The patient has a diagnosis of squamous cell carcinoma of the head and neck in the following anatomical areas: non-mobile base of the tongue, oral pharynx, nasal pharynx, hypo-pharynx and larynx.
  • The patient is pregnant or lactating.
  • The patient has clinical or radiological evidence of metastatic cancer to the regional lymph nodes.
  • Patients with a history of neck dissection, or gross injury to the neck that would preclude reasonable surgical dissection for this study, or radiotherapy to the neck.
  • Patients who have had other nuclear imaging studies conducted within 15 days or consenting.
Show all 9Show fewer
  • The patient is actively receiving systemic cytotoxic chemotherapy.
  • Patient is currently participating in another investigational drug study or participated within 30 days prior to consenting.
  • Patient is on immunosuppressive or anti-monocyte or immunomodulatory therapy.

Trial locations and contacts

13 sites in 1 country.

13 sites in 1 country

United States13 sites

  • University of Michigan Medical Center

    Ann Arbor, Michigan, 48109

  • University of Alabama, Birmingham

    Birminham, Alabama, 35294

  • University of Missouri-Ellis Fischel Cancer Center

    Columbia, Missouri, 65203

  • The Ohio State University Comprehensive Cancer Center

    Columbus, Ohio, 43210

  • Duke University Medical Center

    Durham, North Carolina, 27710

  • MD Anderson

    Houston, Texas, 77030

  • University of Mississippi

    Jackson, Mississippi, 39216

  • University of Kansas Medical Center

    Kansas City, Kansas, 66160

  • Moores UCSD Cancer Center

    La Jolla, California, 92093

  • University of Miami, Sylvester Comprehensive Cancer Center

    Miami, Florida, 33136

  • University of Nebraska

    Omaha, Nebraska, 68198

  • Thomas Jefferson University

    Philadelphia, Pennsylvania, 19107

  • San Diego VA Hospital

    San Diego, California, 92161

Other trials in United States

About this study

Official title: A Ph 3, Prospective, Open-Label, Multicenter Study of Lymphoseek®-Identified Sentinel Lymph Nodes (SLNs) Relative to the Path Status of Non SLN in an Elective Neck Dissection in Cutaneous Head and Neck and Intraoral Squamous Cell Carcinoma

The purpose of this study is to determine the false negative rate (FNR) associated with Lymphoseek-identified sentinel lymph nodes (SLNs) relative to the pathological status of non-sentinel lymph nodes in elective neck dissection (END) in head \& neck squamous cell carcinoma (HNSCC). NEO3-06 (this study) is a Phase 3 clinical trial designed to supplement NEO3-05, a completed Phase 3 clinical trial conducted in patients with breast cancer or melanoma. NEO3-05 was designed to establish Lymphoseek as an effective radio-diagnostic agent to be used in the intraoperative localization of lymph tissue (nodes) in the lymphatic pathway draining the primary site of a tumor.

Being tested
Lymphoseek
Keywords
HNSCC
Medical subject headings
Squamous Cell Carcinoma of Head and Neck

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LymphoseekDrug

    Also called Tc-99m Tilmanocept (Lymphoseek)

    Single injection of 50 micrograms Lymphoseek radiolabeled with either 0.5 mCi (for same day surgery) or 2.0 mCi (for next day surgery) of Tc 99m

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. False Negative Rate (FNR)

    The FNR is calculated as a percentage from the ratio of false negatives to the sum of true positives plus false negatives. The FNR point estimate was the observed rate and was made on a per-patient basis relative to patients with pathology-positive nodes.

    Measured: Surgery after injection of Lymphoseek

Secondary outcomes (3)

  1. Negative Predictive Value (NPV)

    The NPV is calculated as a percentage from the ratio of true negatives to the sum of true negatives plus false negatives. The NPV point estimate was the observed rate and was made on a per-patient basis relative to patients predicted to be pathology-negative.

    Measured: Surgery after injection of Lymphoseek

  2. Overall Accuracy

    The overall accuracy is calculated as a percentage from the ratio of (true positives + true negatives) / (true positives + false negatives + true negatives). The overall accuracy point estimate was the observed rate and was made on a per-patient basis relative to all patients in the intent-to-treat population.

    Measured: Surgery after injection of Lymphoseek

  3. Lymph Node Detection Rate

    The rate of the subjects for whom Lymphoseek identified at least 1 sentinel lymph node. The detection rate point estimate was the observed rate and was made on a per-patient basis relative to all patients in the intent-to-treat population.

    Measured: Surgery after injection of Lymphoseek

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Jun 2009 (estimated)
  2. Study startMay 2009
  3. Primary completionAug 2013
  4. Study completionAug 2013

Why it stopped: The trial was terminated early based on an interim review by the Data and Safety Monitoring Committee for positive efficacy outcome and no safety concerns.

Resources

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
101 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00911326
Sponsor's protocol ID
NEO3-06
Status last verified
Aug 2014
First submitted
28 May 2009
Last updated
8 Aug 2014
Data monitoring committee
Yes

Publications

  • Agrawal A, Civantos FJ, Brumund KT, Chepeha DB, Hall NC, Carroll WR, Smith RB, Zitsch RP, Lee WT, Shnayder Y, Cognetti DM, Pitman KT, King DW, Christman LA, Lai SY. [(99m)Tc]Tilmanocept Accurately Detects Sentinel Lymph Nodes and Predicts Node Pathology Status in Patients with Oral Squamous Cell Carcinoma of the Head and Neck: Results of a Phase III Multi-institutional Trial. Ann Surg Oncol. 2015 Oct;22(11):3708-15. doi: 10.1245/s10434-015-4382-x. Epub 2015 Feb 11.

    PubMed 25670018

  • Marcinow AM, Hall N, Byrum E, Teknos TN, Old MO, Agrawal A. Use of a novel receptor-targeted (CD206) radiotracer, 99mTc-tilmanocept, and SPECT/CT for sentinel lymph node detection in oral cavity squamous cell carcinoma: initial institutional report in an ongoing phase 3 study. JAMA Otolaryngol Head Neck Surg. 2013 Sep;139(9):895-902. doi: 10.1001/jamaoto.2013.4239.

    PubMed 24051744

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Lymphoseek in people with Head and Neck Squamous Cell Carcinoma (HNSCC), run by Navidea Biopharmaceuticals at 13 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 11 inclusion and 9 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 8 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 13 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 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?

Yes. Results are posted in the registry (first posted 8 Aug 2014). 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?

False Negative Rate (FNR) (time frame: Surgery after injection of Lymphoseek). 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 NCT00911326, which also lists 2 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 8 Aug 2014.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in