Rectal CancerNCT02112240
Feasibility Study to Develop Sentinel Lymph Node Mapping in Rectal Cancer Patients
A study testing Intraoperative Mobile Gamma Camera imaging, Endoscopic injection of 99mTc-sulfur colloid and Endoscopic injections of Spot in people with Rectal Cancer, run by University of Virginia at 1 site in United States.
Trial summary
The purpose of this study is to see if investigators can develop a technique to identify sentinel lymph nodes in the rectum for rectal cancer patients with the use of a radiotracer (Tc-sulfur colloid), a dye (Spot), and imaging, both pre- and intraoperatively. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rectal Cancer
- What is being tested?
- Intraoperative Mobile Gamma Camera imaging, Endoscopic injection of 99mTc-sulfur colloid and Endoscopic injections 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
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- May 2013to Feb 2017
- 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 with stage I,II, or III rectal cancer undergoing standard trans- abdominal low anterior resection or abdominoperineal resection surgery at the University of Virginia
- 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
- Participants 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
University of Virginia
Charlottesville, Virginia, 22908
About this study
Official title: Novel Sentinel Lymph Node Mapping Technique in Early Stage Rectal Cancer
The purpose of this study is to see if investigators can develop a technique to identify sentinel lymph nodes in the rectum for rectal cancer patients with the use of a radiotracer (Tc-sulfur colloid), a dye (Spot), and imaging, both pre- and intraoperatively. Eligible patients are those with stage I-III rectal cancer undergoing standard low anterior resection or abdominoperineal resection.
Investigators hypothesize that use of a unique intraoperative lymphatic mapping technique using a mobile gamma camera will identify the sentinel lymph node in patients with rectal cancer with greater than 80% sensitivity.
Read more
Subjects will receive injections of the tracer and dye prior to surgery, have preoperative SPECT/CT imaging to be used as a guide to the rectal lymphatic system and then proceed to their scheduled surgery. During surgery, images of the rectum will be taken with a unique mobile gamma camera prior to removal and upon resection.
If surgeons are able to identify the sentinel lymph nodes surrounding the rectal tumor, the hope is to combine this technique with a less invasive surgery called transanal endoscopic microsurgery (TEM) for early stage rectal cancer patients.
- Conditions
- Rectal Cancer
- Being tested
- Intraoperative Mobile Gamma Camera imaging, Endoscopic injection of 99mTc-sulfur colloid, Endoscopic injections of Spot, Preoperative flexible sigmoidoscopy, SPECT/CT
- Keywords
- sentinel lymph node, lymphatic mapping, rectal tumor
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intraoperative Mobile Gamma Camera imagingOther
Intraoperative images will be taken with a unique mobile gamma camera to identify sentinel lymph nodes in the rectum.
Endoscopic injection of 99mTc-sulfur colloidDrug
Also called Tc-sulfur colloid
Radiotracer injection around the rectal tumor for pre- and intra-operative imaging.
Endoscopic injections of SpotOther
Dye injection for tattooing rectal tumor prior to surgical resection.
Preoperative flexible sigmoidoscopyProcedure or surgery
Flexible sigmoidoscopy prior to surgery to facilitate endoscopic injections of radiotracer and dye.
SPECT/CTRadiation
Preoperative imaging to identify lymph nodes in rectum.
| Study group | Role | What they receive |
|---|---|---|
| Surgery with pre- and intra-op imaging | Experimental | Subjects will have a preoperative flexible sigmoidoscopy where they will receive an endoscopic injection of 99mTc-sulfur colloid (up to 0.5 mCi) and 3 to 5 cc of circumferential endoscopic injections of Spot. A SPECT/CT will be performed prior to surgery to identify lymph nodes in the rectum. Subjects will proceed to their standard surgery. Intraoperative mobile gamma camera imaging of the rectum will occur before and after resection in attempt to identify sentinel lymph nodes. Receives: Other: Intraoperative Mobile Gamma Camera imaging; Drug: Endoscopic injection of 99mTc-sulfur colloid; Other: Endoscopic injections of Spot; Procedure: Preoperative flexible sigmoidoscopy; Radiation: SPECT/CT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluating the sensitivity of identifying the sentinel lymph node using a unique mobile gamma camera intraoperatively.
The primary endpoint is the sensitivity of sentinel lymph node (SLN) detection by the technique which will be estimated by the number of SLNs detected by the technique divided by the number noted at surgery or on final pathology review. 90% confidences interval around the estimate will help guide interpretation of the results.
Measured: At the time of surgery and the time of pathological review, an expected average of 7 days.
Secondary outcomes (1)
Feasibility
Descriptive summaries will be used to list any complications that may have occurred pre-, intra- or post-operatively. Frequency and location of the sentinel lymph node (SLN) with respect to the tumor prior to surgery will be noted. In addition the location of the SLN in relation to the tumor will be documented during pathologic examination with the pathologist and surgeon to assess the feasibility of excision with transanal endoscopic microsurgery.
Measured: From the time of tracer and dye injections to 30 day postoperative visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2014 (estimated)
- Study startMay 2013
- Primary completionFeb 2017 (estimated)
Why it stopped: No accrual. New study opening with modified technique.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rectal CancerStudies 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Virginia
- Sponsor type
- University, hospital or other
- Collaborators
- American Cancer Society, Inc.
- Responsible party
- Principal investigator, Traci Hedrick, MD, University of Virginia
- Investigators
- Traci L Hedrick, MD, Principal investigator, University of Virginia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02112240
- Sponsor's protocol ID
- 16746
- Status last verified
- Jul 2016
- First submitted
- 20 Mar 2014
- Last updated
- 15 Jul 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 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
- NCT02112240
- Acronym / sponsor ID
- 16746
- Conditions
- Rectal Cancer
- Keywords
- sentinel lymph node, lymphatic mapping, rectal tumor
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No accrual. New study opening with modified technique.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of VirginiaUniversity, hospital or other
- Collaborators
- American Cancer Society, Inc.
- Study start
- May 2013
- Primary completion
- Feb 2017 (estimated)
- First posted
- 11 Apr 2014 (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 see if investigators can develop a technique to identify sentinel lymph nodes in the rectum for rectal cancer patients with the use of a radiotracer (Tc-sulfur colloid), a dye (Spot), and imaging, both pre- and intraoperatively. Eligible patients are those with stage I-III rectal cancer undergoing standard low anterior resection or abdominoperineal resection.
Investigators hypothesize that use of a unique intraoperative lymphatic mapping technique using a mobile gamma camera will identify the sentinel lymph node in patients with rectal cancer with greater than 80% sensitivity.
Subjects will receive injections of the tracer and dye prior to surgery, have preoperative SPECT/CT imaging to be used as a guide to the rectal lymphatic system and then proceed to their scheduled surgery. During surgery, images of the rectum will be taken with a unique mobile gamma camera prior to removal and upon resection.
If surgeons are able to identify the sentinel lymph nodes surrounding the rectal tumor, the hope is to combine this technique with a less invasive surgery called transanal endoscopic microsurgery (TEM) for early stage rectal cancer patients.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Surgery with pre- and intra-op imaging | Experimental | Other: Intraoperative Mobile Gamma Camera imaging, Drug: Endoscopic injection of 99mTc-sulfur colloid, Other: Endoscopic injections of Spot, Procedure: Preoperative flexible sigmoidoscopy, Radiation: SPECT/CTSubjects will have a preoperative flexible sigmoidoscopy where they will receive an endoscopic injection of 99mTc-sulfur colloid (up to 0.5 mCi) and 3 to 5 cc of circumferential endoscopic injections of Spot. A SPECT/CT will be performed prior to surgery to identify lymph nodes in the rectum. Subjects will proceed to their standard surgery. Intraoperative mobile gamma camera imaging of the rectum will occur before and after resection in attempt to identify sentinel lymph nodes. |
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 with stage I,II, or III rectal cancer undergoing standard trans- abdominal low anterior resection or abdominoperineal resection surgery at the University of Virginia
- Willing and able to give written informed consent
Key exclusion criteria (5 listed)
- Patients less than 18 years of age
- Women who are pregnant and/or breastfeeding
- Prisoners
- Unable to give written informed consent
- Participants with medical contradictions or have potential problems complying with the requirements of the protocol, in the opinion of the investigator
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 |
|---|---|---|
| Intraoperative Mobile Gamma Camera imagingIntraoperative images will be taken with a unique mobile gamma camera to identify sentinel lymph nodes in the rectum. | Other | Surgery with pre- and intra-op imaging |
| Endoscopic injection of 99mTc-sulfur colloidAlso: Tc-sulfur colloidRadiotracer injection around the rectal tumor for pre- and intra-operative imaging. | Drug | Surgery with pre- and intra-op imaging |
| Endoscopic injections of SpotDye injection for tattooing rectal tumor prior to surgical resection. | Other | Surgery with pre- and intra-op imaging |
| Preoperative flexible sigmoidoscopyFlexible sigmoidoscopy prior to surgery to facilitate endoscopic injections of radiotracer and dye. | Procedure or surgery | Surgery with pre- and intra-op imaging |
| SPECT/CTPreoperative imaging to identify lymph nodes in rectum. | Radiation | Surgery with pre- and intra-op imaging |
Primary outcome
Evaluating the sensitivity of identifying the sentinel lymph node using a unique mobile gamma camera intraoperatively.
Time frame: At the time of surgery and the time of pathological review, an expected average of 7 days.
The primary endpoint is the sensitivity of sentinel lymph node (SLN) detection by the technique which will be estimated by the number of SLNs detected by the technique divided by the number noted at surgery or on final pathology review. 90% confidences interval around the estimate will help guide interpretation of the results.
1 secondary outcome
Feasibility
Time frame: From the time of tracer and dye injections to 30 day postoperative visit
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 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 L 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 Intraoperative Mobile Gamma Camera imaging, Endoscopic injection of 99mTc-sulfur colloid and Endoscopic injections of Spot in people with Rectal Cancer, 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 5 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: withdrawn, as of the sponsor's last update on 15 Jul 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Evaluating the sensitivity of identifying the sentinel lymph node using a unique mobile gamma camera intraoperatively. (time frame: At the time of surgery and the time of pathological review, an expected average of 7 days.). 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 Jul 2016.