Rectal CancerNCT05336643
Radioisotope and Fluorescence Guidance in Rectal Cancer
A study testing Radiofluorescence in people with Rectal Cancer and Lymph Node Metastasis, run by University College, London at 1 site in United Kingdom.
Trial summary
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Rectal Cancer, Lymph Node Metastasis
- What is being tested?
- Radiofluorescence
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jan 2023to Apr 2024
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Rectal Cancer, Lymph Node Metastasis
- Being tested
- Radiofluorescence
- Medical subject headings
- Rectal Neoplasms, Lymphatic Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RadiofluorescenceDevice
Assessment of pelvic sidewall with Firefly and Sensei
| Study group | Role | What they receive |
|---|---|---|
| Radioisotope and fluorescence guidance | Experimental | 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. Receives: Device: Radiofluorescence |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lymph node detection with indocyanine green and near-infrared light source
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".
Measured: 12 months
Lymph node detection with technetium 99m colloid and SENSEI gamma probe
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".
Measured: 12 months
Secondary outcomes (6)
Radioactive count of identified lymph nodes (MBq)
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)
Measured: 12 months
Background radioactive count (MBq)
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)
Measured: 12 months
Time to lymph node identification (seconds)
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
Measured: 12 months
Usability of drop in probe (System usability scale)
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)
Measured: 12 months
Lymph nodes identified on SPECTCT
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.
Measured: 12 months
Concordance of nodes seen on PET MRI/CT and SPECTCT
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 (%)
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2022
- Study startJan 2023 (estimated)
- Primary completionJan 2023 (estimated)
- Study completionApr 2024 (estimated)
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.
- More trials run by University College, LondonThe 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 N/A
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Open label, single arm, feasibility study for a medical device
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University College, London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Simon Wan, Principal investigator, University College London Hospitals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05336643
- Sponsor's protocol ID
- 147974
- Other IDs
- 307317
- Status last verified
- Oct 2022
- First submitted
- 30 Mar 2022
- Last updated
- 1 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: As this is a small pilot study there is no plan to publish IPD. However, if requested by researchers then it can be shared.
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pelvic Side Wall Lymph Node Detection in Rectal Cancer Using Dual Radioisotope and Fluorescence Guidance
- ClinicalTrials.gov ID
- NCT05336643
- Acronym / sponsor ID
- 147974
- Conditions
- Rectal Cancer, Lymph Node Metastasis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- University College, LondonUniversity, hospital or other
- Study start
- Jan 2023 (estimated)
- Primary completion
- Jan 2023 (estimated)
- Study completion
- Apr 2024 (estimated)
- First posted
- 20 Apr 2022 (actual)
- 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.
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.
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 design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Open label, single arm, feasibility study for a medical device
| Arm | Type | Receives |
|---|---|---|
| Radioisotope and fluorescence guidance | Experimental | Device: RadiofluorescencePatients 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- 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
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 |
|---|---|---|
| RadiofluorescenceAssessment of pelvic sidewall with Firefly and Sensei | Device | Radioisotope and fluorescence guidance |
Primary outcome
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".
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".
6 secondary outcomes
Radioactive count of identified lymph nodes (MBq)
Time frame: 12 months
Background radioactive count (MBq)
Time frame: 12 months
Time to lymph node identification (seconds)
Time frame: 12 months
Usability of drop in probe (System usability scale)
Time frame: 12 months
Lymph nodes identified on SPECTCT
Time frame: 12 months
Concordance of nodes seen on PET MRI/CT and SPECTCT
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2022.
- Individual participant dataSharing planned: Yes. As this is a small pilot study there is no plan to publish IPD. However, if requested by researchers then it can be shared.
Related trials for Rectal Cancer
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingObservational study
Pre- and On-treatment Multi-omics Profiling of Locally Advanced Rectal Cancer
Rectal Neoplasms
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
RecruitingPhase 2
Tislelizumab in People With Colorectal Cancer
Colorectal Cancer
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.
Simon Wan principal investigator
University College London Hospitals
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Radiofluorescence in people with Rectal Cancer and Lymph Node Metastasis, run by University College, London at 1 site in United Kingdom.
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 5 inclusion and 3 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 1 Nov 2022. 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 Kingdom. 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 Tom Pampiglione, BMBS (02034479928, uclh.randd@nhs.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lymph node detection with indocyanine green and near-infrared light source (time frame: 12 months). 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 1 Nov 2022.