Magnetic Particle-ICG Lymph Node Mapping in Colorectal Ca... | NCT05092750

Studies
Magnetic Particle-ICG Lymph Node Mapping in Colorectal Cancer

NCT05092750

Sponsor

M.D. Anderson Cancer Center

Status

Withdrawn

Last Update Posted

Sep 28, 2023Actual

Enrollment

0Actual

Phase

Phase 1Phase 2

Conditions

Colorectal Cancer

Interventions

FerroTraceTM
indocyanine green (ICG)

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2023

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

0 accrual

Expanded Access Info

Start Date

Sep 15, 2021Actual

Primary Completion Date

Aug 29, 2023Actual

Completion Date

Aug 29, 2023Actual

First Submitted Date

Sep 21, 2021

First Submission Date that Met QC Criteria

Oct 12, 2021

First Posted Date

Oct 26, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 25, 2023

Last Update Posted Date

Sep 28, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

PRIMARY:

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

SECONDARY:

1. To determine the additional positive diagnostic value of adding sentinel lymph node mapping to lymphadenectomy by assessing the SLNs with detailed immunochemistry versus the normal H&E staining pathology tests.

PRIMARY END POINTS:

Feasibility: Number of registered patients who complete all study procedures with at least one sentinel node identified.
Safety: Rate of any grade III or greater toxicity attributable to FerroTrace injection, evaluated using the Common Terminology Criteria for Adverse Events (CTCAE) v. 5.0. Adverse events according to general peri-operative complications.

SECONDARY ENDPOINTS:

The identification rate and number of FerroTrace-positive lymph nodes for each patient.
Incidence of pathological upstaging of LN metastasis status by the addition of (non-routine) serial H&E and immunohistochemistry in the pathological assessment of identified FerroTrace-positive lymph nodes.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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: FerroTraceTM Drug: indocyanine green (ICG)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
FerroTraceTM	Device	A magnetic	FerroTraceTM (magnetic tracer)
indocyanine green (ICG)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion criteria:

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

Exclusion criteria:

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*

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
George Chang	M.D. Anderson Cancer Center	Principal Investigator

Locations

Not provided

Label	URL
M D Anderson Cancer Center	View source

Condition Browse Module

MeSH Terms

ID	Term
D015179	Colorectal Neoplasms

Ancestor Terms

ID	Term
D007414	Intestinal Neoplasms
D005770	Gastrointestinal Neoplasms
D004067	Digestive System Neoplasms
D009371	Neoplasms by Site

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D007208	Indocyanine Green

Ancestor Terms

ID	Term
D007211	Indoles
D006574	Heterocyclic Compounds, 2-Ring
D000072471	Heterocyclic Compounds, Fused-Ring
D006571	Heterocyclic Compounds

Browse Leaves

Not provided

Browse Branches

Not provided