Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT03405142 |
| Other study ID # |
IRB-43013 |
| Secondary ID |
NCI-2017-02425EN |
| Status |
Completed |
| Phase |
Phase 2
|
| First received |
|
| Last updated |
|
| Start date |
August 1, 2019 |
| Est. completion date |
April 27, 2021 |
Study information
| Verified date |
October 2022 |
| Source |
Stanford University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
This phase 2 trial studies how well panitumumab-IRDye800 works in identifying head and neck
cancer that has spread to the lymph nodes in patients with head and neck cancer.
Panitumumab-IRDye800 may help surgeons to identify metastatic lymph nodes during surgical
removal of the primary tumor and/or lymph nodes of the neck with equal or better accuracy
than the current methods.
Description:
Detecting progression of squamous cell carcinoma of the head and neck (SCCHN) is clinically
challenging, with the transition from Stage 2 (no metastasis) to Stage 3 or 4 (minimally to
significantly metastatic) representing a significant and adverse clinical milestone. SCCHN
often spreads by movement of metastatic cells through the lymphatic system. Often, these
cells are retained in various lymph nodes (LNs), of which there are over 150 on each side of
the head and neck. Logically, the objective of neck dissection would be the removal of
obvious cancer and any LNs containing metastatic cells. However, with visual or even
radiologic identification of cancerous LNs was challenging at best, definitive assessment of
the spread of the cancer must be made on excised tissue in the clinical laboratory by
pathologic assessment. Historically, a marker of successful neck dissection for SCCHN was
excision of sufficient LNs such that the extent of tumor-positive LNs would be demonstrated
by pathology. Accordingly, many LNs are excised that turn out to be negative for invasive
tumor cells. Unfortunately, neck dissection is often accompanied by significant morbidity,
such as shoulder dysfunction or injury to the cranial nerve XI or other nerves causing
persistent pain, as well as anatomic deformities such as scapular flaring, droop, and
protraction. In recent years, a more limited dissection procedure known as sentinel lymph
node biopsy (SNB) has become common, with the advantage of being less invasive, and targeted
to only the LNs believed to the primary drainage of the tumor. Sentinel lymph nodes are those
believed to be most likely to collect tumor cells migrating from the tumor lesion. The goal
of SNB is a more precise identification of those LNs that have or are likely to have
metastatic cells, with fewer LNs collected and less morbidity. Pathological assessment of the
SNBs enhances clinical decision making for further treatment. While SNB represents an overall
improvement, there remains opportunity for better detection of metastatic LNs with less
morbidity.
In this study, the specific medical imaging scan is known as lymphoscintigraphy and is
conducted as single-photon emission computerized tomography (SPECT) scan with computed
tomography (CT), collectively "SPECT/CT" using the radiolabel Lymphoseek (99mTc Tilmanocept).
Lymphoseek is administered as 4 injections to LNs that are in the immediate vicinity of the
known tumor lesion.
The surgical procedure is known as lymphadenectomy, meaning excision of lymph nodes. In this
study, the excised lymph nodes are those suspected as being positive for malignancy and the
basis of they as SPECT/CT lymphoscintigraphy.
The panitumumab-IRDye800 agent is intended to bind to cancer cells, and enable detection of
those cells on the basis of IRDye800 fluorescence. The panitumumab-IRDye800 is administered
as an intravenous infusion over 15 minutes. The label is specific to a marker on tumor cells,
and migrates through the body and adheres to cancer cells, permitting their identification
visually or by fluorescence detectors. Immediately before and after excision, the area around
the lymph nodes are evaluated for the fluorescent signal of the panitumumab-IRDye800.
Additional areas of panitumumab-IRDye800 may be excised. The potential advantage of
panitumumab-IRDye800 labeling is that signaling is assessed intraoperatively, and this may
enable more accurate and more precise determination of the tumor in LNs and other tissue.
In this study, participants with SCCHN that is T1 or T2 stage and node-negative (ie, cN0)
(Cohort 1) will undergo labeling procedures with Lymphoseek (99mTc Tilmanocept), a regular
medical care radiolabel and also investigational panitumumab-IRDye800. Participants whose
SCCHN is node positive and any T stage (Cohort 2) can participate and undergo labeling with
investigational panitumumab-IRDye800 alone.
PRIMARY OBJECTIVES:
To determine if near-infrared fluorescence imaging of panitumumab-IRDye800 can identify
metastatic disease in regional neck lymph nodes of patients with head and neck squamous cell
carcinoma (HNSCC).
SECONDARY OBJECTIVES:
Determine if panitumumab-IRDye800 can identify sentinel nodes with the same accuracy as
technetium Tc 99m-labeled tilmanocept (Lymphoseek).
OUTLINE:
Beginning 2-5 days before surgery, patients receive panitumumab IRDye800 intravenously (IV)
over 60 minutes. On the day before surgery, patients also receive technetium Tc 99m-labeled
tilmanocept via injection and undergo lymphoscintigraphy and single photon emission computed
tomography/computed tomography (SPECT/CT).
After completion of study, patients are followed up for 30 days.
