Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT01902953 |
| Other study ID # |
2013-02-05 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
Phase 2
|
| First received |
|
| Last updated |
|
| Start date |
March 2013 |
| Est. completion date |
June 2016 |
Study information
| Verified date |
June 2021 |
| Source |
Maimonides Medical Center |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
45 patients undergoing a colon (large bowel/intestine)removal operation for the diagnosis of
colon cancer will be included in this study. During colon operation the affected portion of
the colon is removed. In addition, lymph nodes are included in the specimen and evaluated by
a pathologist. Analysis of the lymph nodes in the specimen are important because this is an
important aspect of determining the stage of the cancer.
Once the standard technique is used for the colon removal operation and the specimen is
removed it will be injected with two drugs to help identify the lymph nodes. One is a blue
dye and the other a radiotracer. The colon and ALL of the lymph nodes will then be sent for
the standard pathologic evaluation. The patient themselves will never be injected with these
drugs being used for research.
Following the standard lymph node evaluation, an additional pathologist at an outside
research facility will further examine the lymph nodes in the specimen using more in depth
techniques which are above and beyond the standard of care.
The results of all the pathologic tests will be conveyed to the surgeon of record to help in
their decision making regarding further treatment.
The study hypothesis is that radiotracer will be at least as effective as blue dye in
identifying the lymph nodes most likely to harbor cancer cells (sentinel nodes). Once
identified, these sentinel nodes can then undergo a more in depth review leading to improved
staging of colorectal cancer and more accurate treatment.
Description:
This study is a single center, open-label, within patient's tissue ex vivo comparative study
of Lymphoseek (Lymphoseek (Technetium Tc 99m Tilmanocept) is a radiotracer that accumulates
in lymphatic tissue by binding to a mannose binding receptor that resides on the surface of
dendritic cells and macrophages. Lymphoseek has a diameter of about 5 nm, which is
substantially smaller than current radiolabeled agents used for targeting lymphoid tissue.
Lymphoseek's small diameter permits enhanced diffusion into lymph nodes and blood
capillaries, resulting in a rapid injection site clearance. Upon entry into the blood, the
agent binds to receptors in the liver or is filtered by the kidney and accumulates in the
bladder.)and vital blue dye (Patent Bleu V) in the detection of excised lymph nodes in
patients with known cancer of the colon.
The colon segment with tumor and the anticipated involved nodal bed will be removed intact.
After the surgical procedure is completed, the specimen is instantly taken to an extra table
in the operating room. It is performed just after the specimen is taken out. The colonic
specimen is incised longitudinally on the antimesenteric side.
Lymphatic mapping is employed on the specimen by using first injection Lymphoseek (50 µg/2
mCi) in 0.1-1.0 ml, followed in 15-30 min by 1 ml 1% blue dye, each injected subserosally and
submucosally around the tumor (peritumoral sites employed) by using tuberculin syringe. After
5-7 minutes of massage with little circulatory movements on the lesion, the marking agents
are moved into the lymphatic paths to the sentinel lymph nodes(SLN)in the mesentery.
By low level diathermy, sharp dissection of lymphatic path(s) to the SLN(s) may be existent.
Blue nodes shall be removed first by visual inspection. This inspection and dissection shall
last not longer than 20 minutes. Each blue node will then be assessed for counts as well as
color and the "hot" rule (3σ) applied as described below.
Following blue node removal, each sentinel lymph node can be removed from the basin and
marked before the specimen is submitted for pathologic appraisal.
The Lymphoseek-designated (localized) lymph nodes are defined as lymph nodes that have a
gamma detector count greater than the sum of 3 square roots of the mean background count
(i.e., standard deviation) added to the mean background count. This is referred to hereafter
as the "3σ rule" and as the "threshold criteria". If the gamma detector used cannot obtain
gamma counts in three 2-second intervals, then one 10-second count may be used to detect
gamma counts. Any lymph node count not meeting this threshold criterion will be considered a
negative (non-localized) finding. The background count may be obtained by taking the 2-second
counts or the 10 second counts with the handheld gamma probe extended at least 100 cm away
from the injection site and the probe pointed away from anyLymphoseek source (syringes,
injection site, isotope-contaminated materials).
Probing of the area will be complete when all selected node counts are negative by use of the
threshold criteria. The surgeon will continue with visualization and palpation according to
local practice to ensure that no grossly positive lymph nodes remain at the site of
resection. To confirm the in vivo procedure, assessment of presence of a blue hue and a set
of three 2-second counts or one 10-second count will be recorded for the excised lymph nodes.
The mean count of the ex vivo lymph nodes will be compared to the mean of room background
counts, and the same threshold criteria used to determine a positive finding for the in vivo
nodes will be applied to the ex vivo specimens.
All removed lymph nodes will be sent to pathology for further evaluation. All lymph nodes
will undergo enhanced pathological evaluation including serial sectioning with H&E staining
as well as immunohistochemical (IHC) markers A- The primary objective of efficacy is the
concordance of in vivo detection rates of Lymphoseek and VBD in excised lymph nodes as tissue
phenotype is confirmed by histology.
B- The primary objective is the assessment of the excised lymph node(s) to confirm the
presence/absence of tumor metastases in all nodes and a contrast of pathology findings in per
agent-found nodes versus all non-agent-based removed nodes.
Secondary evaluations will include localization rates (identification of any hot and/or blue
node), degree of localization (node number/patient's ex vivo total tissue), counts localized
per node, and time to localization and stabilization.
