Trial Outcomes & Findings for Evaluation of Sentinel Lymph Nodes in Head and Neck Squamous Cell Carcinoma (NCT NCT00911326)
NCT ID: NCT00911326
Last Updated: 2014-08-08
Results Overview
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.
TERMINATED
PHASE3
101 participants
Surgery after injection of Lymphoseek
2014-08-08
Participant Flow
Participant milestones
| Measure |
Lymphoseek
Intraoral and cutaneous (head and neck) squamous cell carcinoma (T1-T4, N0, M0) patients to receive a single dose of 50 µg Lymphoseek radiolabeled with 0.5 or 2.0 mCi Tc 99m for sentinel lymph node biopsy and elective neck dissection of cervical lymph nodes.
|
|---|---|
|
Overall Study
STARTED
|
101
|
|
Overall Study
COMPLETED
|
85
|
|
Overall Study
NOT COMPLETED
|
16
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Evaluation of Sentinel Lymph Nodes in Head and Neck Squamous Cell Carcinoma
Baseline characteristics by cohort
| Measure |
Lymphoseek
n=85 Participants
Enrolled patients who were administered any injection of Lymphoseek.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=39 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
53 Participants
n=39 Participants
|
|
Age, Categorical
>=65 years
|
32 Participants
n=39 Participants
|
|
Age, Continuous
|
60.8 years
STANDARD_DEVIATION 12.8 • n=39 Participants
|
|
Sex: Female, Male
Female
|
21 Participants
n=39 Participants
|
|
Sex: Female, Male
Male
|
64 Participants
n=39 Participants
|
|
Region of Enrollment
United States
|
85 participants
n=39 Participants
|
|
Clinical tumor stage
T1
|
26 participants
n=39 Participants
|
|
Clinical tumor stage
T2
|
46 participants
n=39 Participants
|
|
Clinical tumor stage
T3
|
7 participants
n=39 Participants
|
|
Clinical tumor stage
T4
|
6 participants
n=39 Participants
|
|
Tumor location
Buccal mucosa
|
8 participants
n=39 Participants
|
|
Tumor location
Cutaneous
|
6 participants
n=39 Participants
|
|
Tumor location
Floor of the mouth
|
20 participants
n=39 Participants
|
|
Tumor location
Lower alveolar ridge
|
3 participants
n=39 Participants
|
|
Tumor location
Mucosal lip
|
1 participants
n=39 Participants
|
|
Tumor location
Oral tongue
|
43 participants
n=39 Participants
|
|
Tumor location
Retromolar gingiva
|
4 participants
n=39 Participants
|
PRIMARY outcome
Timeframe: Surgery after injection of LymphoseekThe 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.
Outcome measures
| Measure |
Intent-to-treat (ITT)
n=83 Participants
All enrolled patients who were injected with Lymphoseek, who underwent surgery, and had at least one lymph node removed (sentinel or non-sentinel) for which the pathology status (presence/absence of tumor cells) was confirmed.
|
|---|---|
|
False Negative Rate (FNR)
|
2.56 % of pathology-positive participants
Interval 0.06 to 13.49
|
SECONDARY outcome
Timeframe: Surgery after injection of LymphoseekThe 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.
Outcome measures
| Measure |
Intent-to-treat (ITT)
n=83 Participants
All enrolled patients who were injected with Lymphoseek, who underwent surgery, and had at least one lymph node removed (sentinel or non-sentinel) for which the pathology status (presence/absence of tumor cells) was confirmed.
|
|---|---|
|
Negative Predictive Value (NPV)
|
97.8 % of participants predicted negative
Interval 88.2 to 99.9
|
SECONDARY outcome
Timeframe: Surgery after injection of LymphoseekThe 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.
Outcome measures
| Measure |
Intent-to-treat (ITT)
n=83 Participants
All enrolled patients who were injected with Lymphoseek, who underwent surgery, and had at least one lymph node removed (sentinel or non-sentinel) for which the pathology status (presence/absence of tumor cells) was confirmed.
|
|---|---|
|
Overall Accuracy
|
98.8 percentage of participants
Interval 93.5 to 99.9
|
SECONDARY outcome
Timeframe: Surgery after injection of LymphoseekThe 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.
Outcome measures
| Measure |
Intent-to-treat (ITT)
n=83 Participants
All enrolled patients who were injected with Lymphoseek, who underwent surgery, and had at least one lymph node removed (sentinel or non-sentinel) for which the pathology status (presence/absence of tumor cells) was confirmed.
|
|---|---|
|
Lymph Node Detection Rate
|
97.6 percentage of participants
Interval 91.6 to 99.7
|
Adverse Events
Lymphoseek
Serious adverse events
| Measure |
Lymphoseek
n=85 participants at risk
Enrolled patients who were administered any injection of Lymphoseek.
|
|---|---|
|
Cardiac disorders
Atrial fibrillation
|
1.2%
1/85 • Overall study
|
|
Gastrointestinal disorders
Mouth haemorrhage
|
1.2%
1/85 • Overall study
|
|
Gastrointestinal disorders
Salivary gland fistula
|
1.2%
1/85 • Overall study
|
|
Infections and infestations
Post procedural infection
|
2.4%
2/85 • Overall study
|
|
Injury, poisoning and procedural complications
Arterial injury
|
1.2%
1/85 • Overall study
|
|
Nervous system disorders
Presyncope
|
1.2%
1/85 • Overall study
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
1.2%
1/85 • Overall study
|
|
Respiratory, thoracic and mediastinal disorders
Chylothorax
|
1.2%
1/85 • Overall study
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
1.2%
1/85 • Overall study
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
1.2%
1/85 • Overall study
|
|
Vascular disorders
Haematoma
|
1.2%
1/85 • Overall study
|
|
Vascular disorders
Hypotension
|
1.2%
1/85 • Overall study
|
Other adverse events
| Measure |
Lymphoseek
n=85 participants at risk
Enrolled patients who were administered any injection of Lymphoseek.
|
|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
7.1%
6/85 • Overall study
|
Additional Information
Dr. Frederick O. Cope, Chief Scientific Officer
Navidea Biopharmaceuticals
Results disclosure agreements
- Principal investigator is a sponsor employee The PI shall not submit a publication to journals or professional societies without the prior written approval of the Sponsor.
- Publication restrictions are in place
Restriction type: OTHER