Endometrial CancerPhase 1NCT02589366
Lymphoseek as Lymphoid Tissue Targeting Agent in Patients With Cancer of the Endometrium
A Phase 1 study testing Lymphoseek plus Vital Blue Dye in people with Endometrial Cancer, run by University of California, San Diego at 1 site in United States.
Trial summary
Part of standard treatment for endometrial cancer is to remove one or more groups of lymph nodes (lymph node dissection). Lymph nodes are small, bean-shaped organs located within the body throughout the lymphatic system (the tissues and organs involved in immunity, which aids in the fight against infection and… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Endometrial Cancer
- What is being tested?
- Lymphoseek plus Vital Blue Dye
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2015to Apr 2018
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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
- The patient has provided written informed consent with Health Insurance Portability and Accountability Act (HIPAA) authorization.
- The patient has diagnosed cancer of the endometrium.
- The patient is a candidate for surgical intervention, with lymph node dissection being a part of the surgical plan.
- The patient is at least 18 years of age at the time of consent.
- The patient has an Eastern Cooperative Group (ECOG) performance status of Grade 0 - 2.
- The patient has a clinical negative node status at the time of study entry (i.e., Tis-4, N0, M0).
- If of childbearing potential, the patient has a negative pregnancy test within 72 hours before administration of Lymphoseek, has been surgically sterilized, or has been postmenopausal for at least 1 year.
Who cannot join
- The patient is pregnant or lactating.
- The patient has clinical or radiological evidence of metastatic cancer including palpably abnormal or enlarged lymph nodes (i.e., all patients should be any T, N0, M0).
- The patient has a known hypersensitivity to Lymphazurin or Lymphoseek.
- The patient has participated in another investigational drug study within 30 days of scheduled surgery.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, San Diego Moores Cancer Center
La Jolla, California, 92093
About this study
Official title: A Phase I, Prospective, Open-Label, Comparison Study of Lymphoseek® and Vital Blue Dye as Lymphoid Tissue Targeting Agents in Patients With Known Cancer of the the Endometrium Who Are Undergoing Lymph Node Dissection
Part of standard treatment for endometrial cancer is to remove one or more groups of lymph nodes (lymph node dissection). Lymph nodes are small, bean-shaped organs located within the body throughout the lymphatic system (the tissues and organs involved in immunity, which aids in the fight against infection and cancer).
The purpose of this study is to compare the safety and ability of Lymphoseek and a Vital Blue Dye (tracing agent) to find lymph nodes that may carry cancer from the tumor through the lymphatic system. Lymphoseek will be injected into the tumor on the day before surgery to remove lymph nodes. Vital Blue Dye will be administered during surgery to trace the cancer as well. The surgeon will remove the lymph nodes as part of routine surgery and will keep track of which lymph nodes are identified by Lymphoseek and Vital Blue Dye. These nodes will be sent to another doctor to view them under a microscope and see if the nodes contain cancer cells.
The hypothesis is that Lymphoseek can be used safely and will be at least as effective as blue dye in identifying the lymph nodes that may have cancer cells.
Read the detailed description
This is an open-label, single center, intra-patient safety and comparison study of Lymphoseek (Technetium Tc 99m Tilmanocept) and vital blue dye for the detection of lymph nodes in patients with endometrial cancer that are undergoing a lymph node dissection as part of their standard medical care.
The day before surgery, patients will have their tumor injected with 50 µg Lymphoseek radiolabeled with 75 megabecquerel (MBq) Tc 99m. Vital signs will be monitored for thirty minutes and then patients will undergo a whole body scan and single photon emission computed tomography/ x-ray computed tomography (SPECT/CT) one to two hours after Lymphoseek injection.
Fourteen to twenty hours after injection of Lymphoseek, patients will have a physical exam and clinical laboratory tests assessed prior to undergoing surgery. Sentinel lymph node identification begins with injection of Vital Blue Dye. Surgical access will be made to the lymphatic basins where nodes are expected to be. Sentinel lymph nodes will be identified by a hand-held gamma counter and/or blue appearance. The threshold criterion for positive "hot" nodes based on radioactivity is a count greater than the quantity of 3 square roots of the mean background count (i.e., standard deviation) added to the mean background count (referred to as the "3σ rule"). Once a lymph node has been identified, in vivo counts should be taken prior to excision. In vivo counts will consist of a set of three 1-second counts over the lymph node. A positive finding (i.e., localization) is a designated "hot" node (described above). Any lymph node count not meeting this threshold criterion will be considered a negative (non-localized) finding. To confirm the in vivo procedure, a set of three 1-second counts will be recorded for the excised lymph nodes. The count of the ex vivo lymph nodes will be compared to the room background counts, and the threshold criterion used to determine a positive finding for the in vivo nodes will be applied to the ex vivo specimens.
A thorough evaluation of the remaining lymphatic basin will be complete when all selected node counts are negative by use of the threshold criterion. 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. After identifying the sentinel lymph nodes, standard lymph node dissection will be performed. All removed lymph nodes are sent to pathology for further evaluation. All removed lymph nodes will be sent to pathology and will be confirmed for radioactive status (due to Lymphoseek) and blue appearance (due to vital blue dye. The pathological evaluation of lymph node(s) will include serial sectioning with H\&E staining as well as immuno-histochemistry (IHC) stain according to institutional practice.
Patients will return for a routine post-operative follow-up visit 7-14 days after surgery for assessment of adverse events.
The primary objective is safety of Lymphoseek as measured by the incidence of adverse events, changes in laboratory values, vital signs and physical exam findings, and the radiation absorbed dose. Secondary evaluations include (1) the number of lymph nodes detected as "hot" by preoperative imaging (whole body scan and SPECT/CT) and intraoperative gamma detection, and (2) the rate of concordance between Lymphoseek and Vital Blue Dye in the in vivo detection of excised lymph nodes.
- Conditions
- Endometrial Cancer
- Being tested
- Lymphoseek plus Vital Blue Dye
- Keywords
- Lymphoseek, endometrial cancer, sentinel lymph node, lymph node dissection
- Medical subject headings
- Endometrial Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lymphoseek plus Vital Blue DyeDrug
Also called Technetium TC 99M, Tilmanocept, Lymphazurin
intrapatient comparison of Lymphoseek with Vital Blue Dye in detecting lymph node metastases
| Study group | Role | What they receive |
|---|---|---|
| Lymphoseek plus Vital Blue Dye | Experimental | Lymphoseek plus Vital Blue Dye: Single dose of 50 µg Lymphoseek radiolabeled with 75 MBq Tc 99m injected pre-operatively followed by next day intra-operative administration of vital blue dye. Receives: Drug: Lymphoseek plus Vital Blue Dye |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Events
Adverse events experienced by the participants and radiation absorbed dose of injected Lymphoseek.
Measured: 0-15 days Postoperatively
Secondary outcomes (2)
Number of Lymphoseek positive lymph nodes detected preoperatively and intraoperatively.
Determination of the number of lymph nodes detected with Lymphoseek by preoperative whole body scan and SPECT/CT imaging and by intraoperative laparoscopic hand held gamma detection device
Measured: 2 days
Number of lymph nodes identified intraoperatively as assessed by visualization and handheld gamma probe detection
Concordance of intraoperative detection rates of Lymphoseek and vital blue dye in histological evaluation and ultrastaging of resected lymph nodes.
Measured: 2 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2015 (estimated)
- Study startNov 2015
- Primary completionApr 2018
- Study completionApr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endometrial CancerStudies of the same condition, open and under way.
- More trials run by University of California, San DiegoThe sponsor's other registered studies.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Collaborators
- Cardinal Health 414, LLC
- Responsible party
- Principal investigator, Michael McHale, University of California, San Diego
- Investigators
- Michael McHale, MD, FACS, Principal investigator, University of California, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02589366
- Sponsor's protocol ID
- HRPP #141163
- Status last verified
- Oct 2018
- First submitted
- 20 Oct 2015
- Last updated
- 15 Oct 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Prospective, Open-Label, Comparison Study of Lymphoseek® and Vital Blue Dye as Lymphoid Tissue Targeting Agents in Patients With Known Cancer of the the Endometrium Who Are Undergoing Lymph Node Dissection
- ClinicalTrials.gov ID
- NCT02589366
- Acronym / sponsor ID
- HRPP #141163
- Conditions
- Endometrial Cancer
- Keywords
- Lymphoseek, endometrial cancer, sentinel lymph node, lymph node dissection
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 2 participants (actual)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Collaborators
- Cardinal Health 414, LLC
- Study start
- Nov 2015
- Primary completion
- Apr 2018 (actual)
- Study completion
- Apr 2018 (actual)
- First posted
- 28 Oct 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Part of standard treatment for endometrial cancer is to remove one or more groups of lymph nodes (lymph node dissection). Lymph nodes are small, bean-shaped organs located within the body throughout the lymphatic system (the tissues and organs involved in immunity, which aids in the fight against infection and cancer).
The purpose of this study is to compare the safety and ability of Lymphoseek and a Vital Blue Dye (tracing agent) to find lymph nodes that may carry cancer from the tumor through the lymphatic system. Lymphoseek will be injected into the tumor on the day before surgery to remove lymph nodes. Vital Blue Dye will be administered during surgery to trace the cancer as well. The surgeon will remove the lymph nodes as part of routine surgery and will keep track of which lymph nodes are identified by Lymphoseek and Vital Blue Dye. These nodes will be sent to another doctor to view them under a microscope and see if the nodes contain cancer cells.
The hypothesis is that Lymphoseek can be used safely and will be at least as effective as blue dye in identifying the lymph nodes that may have cancer cells.
Detailed description
This is an open-label, single center, intra-patient safety and comparison study of Lymphoseek (Technetium Tc 99m Tilmanocept) and vital blue dye for the detection of lymph nodes in patients with endometrial cancer that are undergoing a lymph node dissection as part of their standard medical care.
The day before surgery, patients will have their tumor injected with 50 µg Lymphoseek radiolabeled with 75 megabecquerel (MBq) Tc 99m. Vital signs will be monitored for thirty minutes and then patients will undergo a whole body scan and single photon emission computed tomography/ x-ray computed tomography (SPECT/CT) one to two hours after Lymphoseek injection.
Fourteen to twenty hours after injection of Lymphoseek, patients will have a physical exam and clinical laboratory tests assessed prior to undergoing surgery. Sentinel lymph node identification begins with injection of Vital Blue Dye. Surgical access will be made to the lymphatic basins where nodes are expected to be. Sentinel lymph nodes will be identified by a hand-held gamma counter and/or blue appearance. The threshold criterion for positive "hot" nodes based on radioactivity is a count greater than the quantity of 3 square roots of the mean background count (i.e., standard deviation) added to the mean background count (referred to as the "3σ rule"). Once a lymph node has been identified, in vivo counts should be taken prior to excision. In vivo counts will consist of a set of three 1-second counts over the lymph node. A positive finding (i.e., localization) is a designated "hot" node (described above). Any lymph node count not meeting this threshold criterion will be considered a negative (non-localized) finding. To confirm the in vivo procedure, a set of three 1-second counts will be recorded for the excised lymph nodes. The count of the ex vivo lymph nodes will be compared to the room background counts, and the threshold criterion used to determine a positive finding for the in vivo nodes will be applied to the ex vivo specimens.
A thorough evaluation of the remaining lymphatic basin will be complete when all selected node counts are negative by use of the threshold criterion. 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. After identifying the sentinel lymph nodes, standard lymph node dissection will be performed. All removed lymph nodes are sent to pathology for further evaluation. All removed lymph nodes will be sent to pathology and will be confirmed for radioactive status (due to Lymphoseek) and blue appearance (due to vital blue dye. The pathological evaluation of lymph node(s) will include serial sectioning with H\&E staining as well as immuno-histochemistry (IHC) stain according to institutional practice.
Patients will return for a routine post-operative follow-up visit 7-14 days after surgery for assessment of adverse events.
The primary objective is safety of Lymphoseek as measured by the incidence of adverse events, changes in laboratory values, vital signs and physical exam findings, and the radiation absorbed dose. Secondary evaluations include (1) the number of lymph nodes detected as "hot" by preoperative imaging (whole body scan and SPECT/CT) and intraoperative gamma detection, and (2) the rate of concordance between Lymphoseek and Vital Blue Dye in the in vivo detection of excised lymph nodes.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lymphoseek plus Vital Blue Dye | Experimental | Drug: Lymphoseek plus Vital Blue DyeLymphoseek plus Vital Blue Dye: Single dose of 50 µg Lymphoseek radiolabeled with 75 MBq Tc 99m injected pre-operatively followed by next day intra-operative administration of vital blue dye. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- The patient has provided written informed consent with Health Insurance Portability and Accountability Act (HIPAA) authorization.
- The patient has diagnosed cancer of the endometrium.
- The patient is a candidate for surgical intervention, with lymph node dissection being a part of the surgical plan.
- The patient is at least 18 years of age at the time of consent.
- The patient has an Eastern Cooperative Group (ECOG) performance status of Grade 0 - 2.
Key exclusion criteria (4 listed)
- The patient is pregnant or lactating.
- The patient has clinical or radiological evidence of metastatic cancer including palpably abnormal or enlarged lymph nodes (i.e., all patients should be any T, N0, M0).
- The patient has a known hypersensitivity to Lymphazurin or Lymphoseek.
- The patient has participated in another investigational drug study within 30 days of scheduled surgery.
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 |
|---|---|---|
| Lymphoseek plus Vital Blue DyeAlso: Technetium TC 99M, Tilmanocept, Lymphazurinintrapatient comparison of Lymphoseek with Vital Blue Dye in detecting lymph node metastases | Drug | Lymphoseek plus Vital Blue Dye |
Primary outcome
Adverse Events
Time frame: 0-15 days Postoperatively
Adverse events experienced by the participants and radiation absorbed dose of injected Lymphoseek.
2 secondary outcomes
Number of Lymphoseek positive lymph nodes detected preoperatively and intraoperatively.
Time frame: 2 days
Number of lymph nodes identified intraoperatively as assessed by visualization and handheld gamma probe detection
Time frame: 2 days
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2018.
- Individual participant dataSharing planned: No
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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 McHale, MD, FACS principal investigator
University of California, San Diego
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Lymphoseek plus Vital Blue Dye in people with Endometrial Cancer, run by University of California, San Diego at 1 site 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 7 inclusion and 4 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 15 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
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?
Adverse Events (time frame: 0-15 days Postoperatively). 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 15 Oct 2018.