NCT05092750

Brief Summary

Study to determine the feasibility of Sentinel Lymph Node (SLN) mapping using novel magnetic tracers (FerroTrace) and indocyanine green (ICG) for colorectal cancer; and to evaluate safety by assessing short term toxicity associated with colonoscopic peritumoral injection of novel magnetic nanoparticles (FerroTrace) and ICG for colorectal cancer.

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Sep 2021

Shorter than P25 for phase_1 colorectal-cancer

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 15, 2021

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

September 21, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

October 26, 2021

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 29, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 29, 2023

Completed
Last Updated

September 28, 2023

Status Verified

September 1, 2023

Enrollment Period

2 years

First QC Date

September 21, 2021

Last Update Submit

September 25, 2023

Conditions

Colorectal Cancer

Outcome Measures

Primary Outcomes (1)

  • To assess the feasibility how the Sentinel Lymph Node (SLN) mapping by using novel magnetic tracers (FerroTrace) and using the indocyanine green (ICG) for colorectal cancer.

    through study completion, an average of 1 year

Study Arms (1)

FerroTraceTM (magnetic tracer)

EXPERIMENTAL

a special type of fluorescent dye called indocyanine green (ICG) during surgery can help surgeons find the lymph nodes that the cancer is most likely to have spread to in colorectal cancer patients.

Device: FerroTraceTMDrug: indocyanine green (ICG)

Interventions

FerroTraceTMDEVICE

A magnetic

FerroTraceTM (magnetic tracer)
indocyanine green (ICG)DRUG

Given by SC injection

FerroTraceTM (magnetic tracer)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 18 or older
  • Willing to provide informed consent
  • Biopsy proven colon or rectal cancer
  • No distant metastases

You may not qualify if:

  • Serious medical comorbidities or other contraindications to surgery +/- adjuvant therapy as determined by the treatment team
  • Previous pelvic radiotherapy or radiotherapy planned prior to surgery
  • Allergy or intolerance to iron oxide compounds
  • Iron overload disorder
  • Allergy or intolerance to iodides
  • Pregnant or lactating women\*

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Links

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Indocyanine Green

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Intervention Hierarchy (Ancestors)

IndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • George Chang

    M.D. Anderson Cancer Center

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 21, 2021

First Posted

October 26, 2021

Study Start

September 15, 2021

Primary Completion

August 29, 2023

Study Completion

August 29, 2023

Last Updated

September 28, 2023

Record last verified: 2023-09