Radioisotope and Fluorescence Guidance in Rectal Cancer

NCT05336643 | Unknown

• 2 other identifiers: 147974307317
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Rectal Cancer; Lymph Node Metastasis

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (6)

• Radioactive count of identified lymph nodes (MBq)

  12 months

• Background radioactive count (MBq)

  12 months

• Time to lymph node identification (seconds)

  12 months

• Usability of drop in probe (System usability scale)

  12 months

• Lymph nodes identified on SPECTCT

  12 months

Study Arms (1)

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.

Device: Radiofluorescence

Interventions

Radiofluorescence DEVICE

Assessment of pelvic sidewall with Firefly and Sensei

Radioisotope and fluorescence guidance

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University College, London: lead

Study Sites (1)

University College London Hospital

London, United Kingdom

Location

MeSH Terms

Conditions

Rectal Neoplasms; Lymphatic Metastasis

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases; Neoplasm Metastasis; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Simon Wan

  University College London Hospitals

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tom Pampiglione, BMBS

CONTACT

02034479928; uclh.randd@nhs.net

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Open label, single arm, feasibility study for a medical device

Study Record Dates

• First Submitted: March 30, 2022
• First Posted: April 20, 2022
• Study Start: January 1, 2023
• Primary Completion: January 1, 2023
• Study Completion: April 1, 2024
• Last Updated: November 1, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR
• Time Frame: Data will be available after completion of the study. In line with University protocols data is stored for 20 years.
• Access Criteria: Other researchers for systematic review and meta-analysis

Locations

GB (1)