Radioisotope and Fluorescence Guidance in Rectal Cancer

October 31, 2022 updated by: University College, London

Pelvic Side Wall Lymph Node Detection in Rectal Cancer Using Dual Radioisotope and Fluorescence Guidance

A study to investigate if pelvic side wall lymph nodes that remain after neo-adjuvant chemoradiotherapy can be identified intraoperatively using dual radioisotope and fluorescence guidance.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Background Total mesorectal excision (TME) revolutionised the management of rectal cancer by improving outcomes and standardising surgical technique. When excising mesorectal lymph nodes, most involved nodes are removed. However, a proportion of lower rectal lymphatic drainage is through the pelvic sidewall (PSW) system, all PSW nodes are left behind in TME. Up to 15% patients with rectal cancer have PSW involvement at presentation, this is associated with increased local recurrence.

Problem There are two main approaches in the management of PSW nodes. In the Western hemisphere, patients are typically staged with pre-operative MRI. Those with nodes undergo neo-adjuvant chemoradiotherapy to downstage the tumour, followed by surgical resection, PSW lymph nodes are left in place. In the East patients undergo PSW lymph node dissection at the time of rectal resection. There is evidence that lymphadenectomy at initial surgery or after chemoradiotherapy improves oncological outcome, though this is at the cost of increased morbidity, worsening urinary and sexual function.

Objective The aim is to make PSW lymph node dissection safer and more targeted. This initial feasibility study, is investigating if PSW lymph nodes can be individually identified using dual modalities, fluorescence, and a radioisotope tracer. The fluorophore indocyanine green (ICG) has been used successfully for lymph node mapping in rectal cancer. ICG and Technetium-99m nanocolloid (Tc99m), a radioisotope, have been used as dual tracers for lymph nodes in gynaecological, esophagogastric and oral surgery, but never in rectal surgery.

Method The investigators have designed an open label, single-centre, feasibility study to investigate if PSW lymph nodes can be identified intra-operatively using a radioisotope and fluorescence. Ten post neo-adjuvant chemotherapy rectal cancer patients will be scheduled for resection. Pre-operatively patients will receive an injection of Tc99m and ICG to the submucosa around the tumour. Patients will undergo single-photon emission computed tomography (SPECT) scanning to identify lymphatic drainage. Intra-operatively, after bowel resection, the surgical team will examine the PSW for lymph nodes using a minimally invasive gamma probe (SENSEI, Lightpoint Medical) to detect Tc99m, and a near infrared camera system (Firefly, Intuitive) to visualise ICG. The primary outcome is intraoperative detection of PSW lymph nodes.

Significance The aim from this feasibility study is to demonstrate that individual PSW nodes can be detected intra-operatively. By proving this technique, the investigators will design a larger study to investigate the oncological outcome of excising individual involved nodes, with the aim of reducing PSW recurrence and surgical morbidity.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
10

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United Kingdom
      • London, United Kingdom
        • University College London Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 18 years of age or older
  • Primary diagnosis of biopsy-proven rectal cancer
  • Scheduled for curative robotic surgery of primary tumour
  • Have signed an approved informed consent form for the study
  • Be willing and able to comply with the study protocol

Exclusion Criteria:

  • Known allergy or history of adverse reaction to Technetium-99m nanocolloid or indocyanine green
  • Pregnant or lactating subjects
  • Subjects who, in the Investigator's and/or designee's opinion, have any medical condition that makes the subject a poor candidate for the investigational procedure, or interferes with the interpretation of study results

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Device Feasibility
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Radioisotope and fluorescence guidance
Patients undergoing curative resection for rectal cancer will receive a peritumoural, submucosal administration of indocyanine green and technetium-99m nanocolloid. Intraoperatively the SENSEI gamma probe and Da Vinci Firefly will be used to identify pelvic side wall lymph nodes.
Device: Radiofluorescence
Assessment of pelvic sidewall with Firefly and Sensei

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Lymph node detection with indocyanine green and near-infrared light source
Time Frame: 12 months
Intraoperative identification of pelvic side wall lymph nodes using fluorescence. After resection of the rectal specimen the near infrared light source will be switched on and the pelvic side wall will be assessed for lymph nodes seen on SPECTCT. Primary outcome will be recorded as "yes" or "no".
12 months
Lymph node detection with technetium 99m colloid and SENSEI gamma probe
Time Frame: 12 months
Intraoperative identification of pelvic side wall lymph nodes using radioisotope. After resection of the rectal specimen the gamma probe will be switched on and the pelvic side wall will be assessed for lymph nodes seen on SPECTCT. Primary outcome will be recorded as "yes" or "no".
12 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Radioactive count of identified lymph nodes (MBq)
Time Frame: 12 months

Usability of drop in gamma probe - effectiveness 1

Intraoperative identification of pelvic side wall lymph nodes using radioisotope. After resection of the rectal specimen the gamma probe will be switched on and the pelvic side wall will be assessed for lymph nodes seen on SPECTCT.

Secondary outcome is the gamma radiation count of identified nodes recorded in megabecquerel (MBq)
12 months
Background radioactive count (MBq)
Time Frame: 12 months

Usability of drop in gamma probe - effectiveness 2

Intraoperative identification of pelvic side wall lymph nodes using radioisotope. After resection of the rectal specimen the gamma probe will be switched on and the pelvic side wall will be assessed for lymph nodes seen on SPECTCT.

Secondary outcome is the gamma radiation count of background radiation, measured underneath camera port, pointing up towards port, recorded in megabecquerel (MBq)
12 months
Time to lymph node identification (seconds)
Time Frame: 12 months

Usability of drop in gamma probe - effectiveness 3

Intraoperative identification of pelvic side wall lymph nodes using radioisotope. After resection of the rectal specimen the gamma probe will be switched on and the pelvic side wall will be assessed for lymph nodes seen on SPECTCT.

Secondary outcome is time taken for lymph node identification, recorded in seconds
12 months
Usability of drop in probe (System usability scale)
Time Frame: 12 months

Usability of drop in gamma probe - satisfaction

Intraoperative identification of pelvic side wall lymph nodes using radioisotope. After resection of the rectal specimen the gamma probe will be switched on and the pelvic side wall will be assessed for lymph nodes seen on SPECTCT.

Secondary outcome is the usability of the SENSEI gamma probe using the System Usability Scale (Score 0-100)
12 months
Lymph nodes identified on SPECTCT
Time Frame: 12 months

In the morning patients receive a peritumoral submucosal injection of technetium 99m nano colloid. After a 4 hour interval they undergo SPECTCT.

Number of lymph nodes identified on SPECTCT.
12 months
Concordance of nodes seen on PET MRI/CT and SPECTCT
Time Frame: 12 months

In the lead up to surgery (>24 hours prior) patients will undergo PET MRI/CT. In the morning patients receive a peritumoral submucosal injection of technetium 99m nano colloid. After a 4 hour interval they undergo SPECTCT.

Percentage of nodes seen on PET MRI/CT seen on SPECTCT (%)
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University College, London

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Simon Wan, University College London Hospitals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2023

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2023

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 30, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 13, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 20, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 1, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 31, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 147974
  • 307317 (Other Identifier: IRAS)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

As this is a small pilot study there is no plan to publish IPD. However, if requested by researchers then it can be shared.

IPD Sharing Time Frame

Data will be available after completion of the study. In line with University protocols data is stored for 20 years.

IPD Sharing Access Criteria

Other researchers for systematic review and meta-analysis

IPD Sharing Supporting Information Type

  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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