A Study to Evaluate Indocyanine Green Lymphangiography to... | NCT04591028

Studies
A Study to Evaluate Indocyanine Green Lymphangiography to Improve Lymphadenectomy in Gastric Cancer Patients

NCT04591028

Sponsor

Mayo Clinic

Status

Withdrawn

Last Update Posted

Jul 19, 2023Actual

Enrollment

0Actual

Phase

Phase 4

Conditions

Gastric Cancer

Interventions

Indocyanine green

Countries

United States

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

Jul 2023

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Lack of funding.

Expanded Access Info

Start Date

Jan 2022Estimated

Primary Completion Date

Jan 2022Estimated

Completion Date

Aug 10, 2022Estimated

First Submitted Date

Oct 15, 2020

First Submission Date that Met QC Criteria

Oct 15, 2020

First Posted Date

Oct 19, 2020Actual

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

Jul 17, 2023

Last Update Posted Date

Jul 19, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Yes

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

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 4

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
Intervention	Other	Injection of Indocyamine Green.	Drug: Indocyanine green

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Indocyanine green	Drug	A one time injection of IDC prior to the day of scheduled surgery.	Intervention

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Positive ICG fluorescence lymph nodes	Total number of lymph nodes removed after surgery that are positive for ICG fluorescence	Approximately 30-90 days after surgery
Disease positive lymph nodes	Number of ICG positive lymph nodes that are also positive for disease	Approximately 30-90 days after surgery
Number of lymph nodes removed for each lymphatic station of gastrectomy	Total number of lymph nodes removed for each lymphatic station of gastrectomy with NIR+ICG vs gastrectomy without NIR+ICG	Approximately 30-90 days after surgery

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients ≥ 18 and ≤ 75 years of age.
Primary gastric adenocarcinoma of any histological subtype confirmed pathologically by endoscopic biopsy.
Clinical stage tumor T1-4a (cT1-4a), N -/+, M0 at preoperative evaluation according to the American Joint Committee on Cancer (AJCC) Cancer Staging Manual Seventh Edition.
No distant metastasis, no direct invasion of adjacent organs such as pancreas and spleen in preoperative exams.
American Society of Anesthesiology score (ASA) class I, II, or III.
Written informed consent.

Exclusion Criteria:

Patients ≤ 18 and ≥ 75 years of age.
History of previous upper abdominal surgery (except laparoscopic cholecystectomy).
History of previous gastrectomy, endoscopic mucosal resection or endoscopic submucosal dissection.
History of allergy to iodine agents.
History of other malignant disease within past five years.
Emergency surgery due to complication caused by gastric cancer, such as bleeding obstruction or perforation.
Patients intraoperatively/postoperatively confirmed as T4b.
Patients intraoperatively confirmed as unable to complete D2 lymph node dissection or R0 dissection.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Enrique F Elli, MD	Mayo Clinic	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Mayo Clinic in Florida		Jacksonville	Florida	32224	United States

Label	URL
Mayo Clinic Clinical Trials	View source

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D013274	Stomach Neoplasms

Ancestor Terms

ID	Term
D005770	Gastrointestinal Neoplasms
D004067	Digestive System Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms

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