Radioisotope and Fluorescence Guidance in Rectal Cancer

Rectal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05336643
• Other study ID #: 147974
• Secondary ID: 307317
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 2023
• Est. completion date: April 2024

Study information

• Verified date: October 2022
• Source: University College, London
• Contact: Tom Pampiglione, BMBS
• Phone: 02034479928
• Email: uclh.randd[@]nhs.net
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 10
• Est. completion date: April 2024
• Est. primary completion date: January 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Lymph Node Metastasis
• Lymphatic Metastasis
• Rectal Cancer
• Rectal Neoplasms

Intervention

Device:
• Radiofluorescence
Assessment of pelvic sidewall with Firefly and Sensei

Locations

Country	Name	City	State
United Kingdom	University College London Hospital	London

Sponsors (1)

Lead Sponsor	Collaborator
University College, London

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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".	12 months
Primary	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".	12 months
Secondary	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)	12 months
Secondary	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)	12 months
Secondary	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	12 months
Secondary	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)	12 months
Secondary	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.	12 months
Secondary	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 (%)	12 months