Rectal NeoplasmsNCT02869152
Sentinel Lymph Node Mapping in Rectal Cancer
A study testing Endoscopic injection of 99mTc-sulfur colloid, Endoscopic injection of ICG and Endoscopic injection of Spot in people with Rectal Neoplasms, run by University of Virginia at 1 site in United States.
Trial summary
The purpose of this study is to develop a technique that allows physicians to identify the first lymph nodes draining from a rectal tumor (the sentinel lymph nodes). Currently, there is no technique used to find these lymph nodes in the rectum during surgery and therefore many patients with rectal cancer need to… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rectal Neoplasms
- What is being tested?
- Endoscopic injection of 99mTc-sulfur colloid, Endoscopic injection of ICG and Endoscopic injection of Spot
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2016to Mar 2019
- Phase
- Interventional
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients undergoing elective transanal endoscopic surgery (TES) at the University of Virginia for rectal neoplasm (polyp with high grade dysplasia, T1N0 tumors < 3cm in the absence of poor pathologic features, patients that refuse radical resection)
- Willing and able to give written informed consent
Who cannot join
- Patients less than 18 years of age
- Women who are pregnant and/or breastfeeding
- Prisoners
- Unable to give written informed consent
- Patients with any of the following:
- Allergy to technetium, Spot and/or ICG
Show all 9Show fewer
- Allergy to iodides
- Severe cardiac disease (hospitalization for cardiac disease in the last year, congestive heart failure, abnormal EKG) or renal disease (Creatinine > 2.0 mg/dL)
- Patients with medical contradictions or have potential problems complying with the requirements of the protocol, in the opinion of the investigator
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
University of Virginia
Charlottesville, Virginia, 22908
Amy Harrigan, 434-982-6532, acm6a@virginia.edu
Traci L Hedrick, MD, MS
About this study
Official title: Novel Sentinel Lymph Node Mapping Technique in Early Stage Rectal Cancer
The purpose of this study is to develop a technique that allows physicians to identify the first lymph nodes draining from a rectal tumor (the sentinel lymph nodes). Currently, there is no technique used to find these lymph nodes in the rectum during surgery and therefore many patients with rectal cancer need to undergo a total rectal resection. Dyes, tracers, imaging and a gamma probe will be used in this study during a standard minimally invasive transanal endoscopic surgery (TES) to try to locate these lymph nodes. If surgeons are able to locate these lymph nodes they will be removed during surgery. If the technique is successfully developed as a result of this research, it could help patients in the future with early stage rectal cancer by allowing doctors to see if their cancer has spread to the lymph nodes of the rectum without having to undergo a total rectal resection. These patients would then be able to undergo a TES combined with a lymph node dissection to gain more knowledge about the stage of their disease. This knowledge would then be used to determine if and what further treatment is necessary for the patient's rectal cancer.
- Conditions
- Rectal Neoplasms
- Being tested
- Endoscopic injection of 99mTc-sulfur colloid, Endoscopic injection of ICG, Endoscopic injection of Spot, Flexible sigmoidoscopy, Endoscopic NIR imaging and gamma probe
- Keywords
- sentinel lymph node, lymphatic mapping, rectal tumor, rectal cancer, early stage
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endoscopic injection of 99mTc-sulfur colloidOther
Radiotracer injection around the rectal tumor for SLN mapping with gamma probe
Endoscopic injection of ICGOther
Dye injection around the rectal tumor for SLN mapping with NIR imaging.
Endoscopic injection of SpotOther
Dye injection for tattooing rectal tumor prior to surgical resection.
Flexible sigmoidoscopyProcedure or surgery
Flexible sigmoidoscopy prior to surgery to facilitate endoscopic injections of radiotracer and dyes.
Endoscopic NIR imaging and gamma probeProcedure or surgery
Endoscopic near infrared (NIR) imaging of ICG and detection of radiotracer with gamma probe after standard removal of rectal neoplasm.
Dissection of sentinel lymph node(s)Procedure or surgery
Surgical removal of identified lymph nodes in the rectum.
| Study group | Role | What they receive |
|---|---|---|
| Intraoperative sentinel lymph node mapping | Experimental | Subjects will come to the OR and undergo a flexible sigmoidoscopy after induction of anesthesia and receive separate endoscopic injections of Spot (up to 5 cc), 99mTc-sulfur colloid (up to 0.5 mCi), and Indocyanine green (ICG) (1 ml). Patient will undergo the standard transanal endoscopic surgery (TES) to remove the rectal neoplasm, exposing the lymph node basin. The sentinel node(s) will be identified using a combination of the gamma probe and fluorescence imaging endoscopically, dissected out, and removed through a transanal approach. Receives: Other: Endoscopic injection of 99mTc-sulfur colloid; Other: Endoscopic injection of ICG; Other: Endoscopic injection of Spot; Procedure: Flexible sigmoidoscopy; Procedure: Endoscopic NIR imaging and gamma probe; Procedure: Dissection of sentinel lymph node(s) |
What is being measured
The primary outcome is the main question the study is designed to answer.
1st Phase: Detection rate of sentinel lymph node in first 6 patients
Data from the first 6 eligible patients will be used to verify feasibility. For this phase, the data need to support a detection rate of at least 50% for the procedure to be considered feasible to move forward with the 2nd phase. The proposed SLNm technique will be declared 'feasible' if at least one SLN is identified per patient. Identification of the SLN in three consecutive patients would provide 80% confidence of successful identification more than 50% of the time. A total sample of size of 6 patients would allow for three refinements in technique if necessary to establish feasibility.
Measured: Throughout first phase of study, an average of 1 year.
2nd Phase: Detection rate of refined protocol in identifying SLN
2nd Phase: Sample size is set at 16 eligible patients. For this study, continued investigation of the proposed technique would be of interest if 70-100% of the SLNs are detected. If at least on SLN is detected in 14 of 16 patients, an observed rate of 87.5%, then the lower limit of a one-sided 90% confidence interval is 70%. Thus, detection of at least one SLN in 14 or more patients out of 16 assessed would provide strong preliminary data for the technique (i.e. SLN is detected in at least 70% of patients). If it's assumed, on average, 1.5 SLN could be identified and excised per patient, then with 24 possible SLN, the estimated rate of SLN positive for disease would have an expected half width (or precision of the estimate) of 12-14%.
Measured: Throughout first phase of study, an average of 1.5 years.
Secondary outcomes (6)
Size of the SLN according to pathologic analysis
Measured: Throughout study, an average of 2.5 years
Location of the SLN according to pathologic analysis
Measured: Throughout study, an average of 2.5 years.
Time required for completion of the protocol
Measured: Throughout study, an average of 2.5 years.
Number of protocol modifications for procedural and/or technical issues
Measured: Throughout study, an average of 2.5 years
Ergonomic optimization of the protocol as measured by operative time
Measured: Throughout study, an average of 2.5 years
Ergonomic optimization of the protocol as measured by surgeon satisfaction
Measured: Throughout study, an average of 2.5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2016 (estimated)
- Study startAug 2016
- Primary completionMar 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rectal NeoplasmsStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 26 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Virginia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Traci Hedrick, MD, University of Virginia
- Investigators
- Traci Hedrick, MD, Principal investigator, University of Virginia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02869152
- Sponsor's protocol ID
- 19120
- Status last verified
- Oct 2016
- First submitted
- 14 Jul 2016
- Last updated
- 31 Oct 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Novel Sentinel Lymph Node Mapping Technique in Early Stage Rectal Cancer
- ClinicalTrials.gov ID
- NCT02869152
- Acronym / sponsor ID
- 19120
- Conditions
- Rectal Neoplasms
- Keywords
- sentinel lymph node, lymphatic mapping, rectal tumor, rectal cancer, early stage
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 26 participants (estimated)
- Lead sponsor
- University of VirginiaUniversity, hospital or other
- Study start
- Aug 2016
- Primary completion
- Mar 2019 (estimated)
- First posted
- 16 Aug 2016 (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.
The purpose of this study is to develop a technique that allows physicians to identify the first lymph nodes draining from a rectal tumor (the sentinel lymph nodes). Currently, there is no technique used to find these lymph nodes in the rectum during surgery and therefore many patients with rectal cancer need to undergo a total rectal resection. Dyes, tracers, imaging and a gamma probe will be used in this study during a standard minimally invasive transanal endoscopic surgery (TES) to try to locate these lymph nodes. If surgeons are able to locate these lymph nodes they will be removed during surgery. If the technique is successfully developed as a result of this research, it could help patients in the future with early stage rectal cancer by allowing doctors to see if their cancer has spread to the lymph nodes of the rectum without having to undergo a total rectal resection. These patients would then be able to undergo a TES combined with a lymph node dissection to gain more knowledge about the stage of their disease. This knowledge would then be used to determine if and what further treatment is necessary for the patient's rectal cancer.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intraoperative sentinel lymph node mapping | Experimental | Other: Endoscopic injection of 99mTc-sulfur colloid, Other: Endoscopic injection of ICG, Other: Endoscopic injection of Spot, Procedure: Flexible sigmoidoscopy, Procedure: Endoscopic NIR imaging and gamma probe, Procedure: Dissection of sentinel lymph node(s)Subjects will come to the OR and undergo a flexible sigmoidoscopy after induction of anesthesia and receive separate endoscopic injections of Spot (up to 5 cc), 99mTc-sulfur colloid (up to 0.5 mCi), and Indocyanine green (ICG) (1 ml). Patient will undergo the standard transanal endoscopic surgery (TES) to remove the rectal neoplasm, exposing the lymph node basin. The sentinel node(s) will be identified using a combination of the gamma probe and fluorescence imaging endoscopically, dissected out, and removed through a transanal approach. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adult patients undergoing elective transanal endoscopic surgery (TES) at the University of Virginia for rectal neoplasm (polyp with high grade dysplasia, T1N0 tumors < 3cm in the absence of poor pathologic features, patients that refuse radical resection)
- Willing and able to give written informed consent
Key exclusion criteria (9 listed)
- Patients less than 18 years of age
- Women who are pregnant and/or breastfeeding
- Prisoners
- Unable to give written informed consent
- Patients with any of the following:
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 |
|---|---|---|
| Endoscopic injection of 99mTc-sulfur colloidRadiotracer injection around the rectal tumor for SLN mapping with gamma probe | Other | Intraoperative sentinel lymph node mapping |
| Endoscopic injection of ICGDye injection around the rectal tumor for SLN mapping with NIR imaging. | Other | Intraoperative sentinel lymph node mapping |
| Endoscopic injection of SpotDye injection for tattooing rectal tumor prior to surgical resection. | Other | Intraoperative sentinel lymph node mapping |
| Flexible sigmoidoscopyFlexible sigmoidoscopy prior to surgery to facilitate endoscopic injections of radiotracer and dyes. | Procedure or surgery | Intraoperative sentinel lymph node mapping |
| Endoscopic NIR imaging and gamma probeEndoscopic near infrared (NIR) imaging of ICG and detection of radiotracer with gamma probe after standard removal of rectal neoplasm. | Procedure or surgery | Intraoperative sentinel lymph node mapping |
| Dissection of sentinel lymph node(s)Surgical removal of identified lymph nodes in the rectum. | Procedure or surgery | Intraoperative sentinel lymph node mapping |
Primary outcome
1st Phase: Detection rate of sentinel lymph node in first 6 patients
Time frame: Throughout first phase of study, an average of 1 year.
Data from the first 6 eligible patients will be used to verify feasibility. For this phase, the data need to support a detection rate of at least 50% for the procedure to be considered feasible to move forward with the 2nd phase. The proposed SLNm technique will be declared 'feasible' if at least one SLN is identified per patient. Identification of the SLN in three consecutive patients would provide 80% confidence of successful identification more than 50% of the time. A total sample of size of 6 patients would allow for three refinements in technique if necessary to establish feasibility.
2nd Phase: Detection rate of refined protocol in identifying SLN
Time frame: Throughout first phase of study, an average of 1.5 years.
2nd Phase: Sample size is set at 16 eligible patients. For this study, continued investigation of the proposed technique would be of interest if 70-100% of the SLNs are detected. If at least on SLN is detected in 14 of 16 patients, an observed rate of 87.5%, then the lower limit of a one-sided 90% confidence interval is 70%. Thus, detection of at least one SLN in 14 or more patients out of 16 assessed would provide strong preliminary data for the technique (i.e. SLN is detected in at least 70% of patients). If it's assumed, on average, 1.5 SLN could be identified and excised per patient, then with 24 possible SLN, the estimated rate of SLN positive for disease would have an expected half width (or precision of the estimate) of 12-14%.
6 secondary outcomes
Size of the SLN according to pathologic analysis
Time frame: Throughout study, an average of 2.5 years
Location of the SLN according to pathologic analysis
Time frame: Throughout study, an average of 2.5 years.
Time required for completion of the protocol
Time frame: Throughout study, an average of 2.5 years.
Number of protocol modifications for procedural and/or technical issues
Time frame: Throughout study, an average of 2.5 years
Ergonomic optimization of the protocol as measured by operative time
Time frame: Throughout study, an average of 2.5 years
Ergonomic optimization of the protocol as measured by surgeon satisfaction
Time frame: Throughout study, an average of 2.5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2016.
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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.
Traci Hedrick, MD principal investigator
University of Virginia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Endoscopic injection of 99mTc-sulfur colloid, Endoscopic injection of ICG and Endoscopic injection of Spot in people with Rectal Neoplasms, run by University of Virginia 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 2 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: status not confirmed, as of the sponsor's last update on 31 Oct 2016. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Amy Harrigan, BS, CCRC (434-982-6532, acm6a@virginia.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
1st Phase: Detection rate of sentinel lymph node in first 6 patients (time frame: Throughout first phase of study, an average of 1 year.). The study lists 2 primary outcomes in all. 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 31 Oct 2016.