search
Back to results

A Study of Intra-operative Imaging in Women With Ovarian Cancer

Primary Purpose

Ovarian Cancer, Ovarian Carcinoma

Status
Recruiting
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Intravenous Indocyanine Green/ICG injection
PINPOINT endoscopic fluorescence imaging system
Endoscopy
Sponsored by
Memorial Sloan Kettering Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Ovarian Cancer focused on measuring Ovarian cancer, PINPOINT, rectosigmoid resection, anastomosis, 21-202, Memorial Sloan Kettering Cancer Center

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleDoes not accept healthy volunteers

Participant Inclusion Criteria

Part 1 (pre-operative):

  • Diagnosed with primary or recurrent ovarian, fallopian tube, or primary peritoneal cancer
  • Scheduled to undergo debulking or cytoreductive surgery
  • Suspected need for a low anterior rectosigmoid resection at the time of a debulking procedure
  • Enrolled and consented before the operation

Part 2 (intra-operative):

  • Completed rectosigmoid resection
  • Surgeon plans to perform colorectal anastomosis

Participant Exclusion Criteria

Part 1 (pre-operative):

  • Documented history of allergic reaction to ICG
  • Not approached for study enrollment before undergoing an unexpected low anterior rectosigmoid resection

Part 2 (intra-operative):

  • Did not undergo rectosigmoid resection intraoperatively
  • Surgical procedure with rectosigmoid resection for any other type of gynecologic malignancy
  • Patient requires permanent colostomy

Sites / Locations

  • Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)Recruiting
  • Memorial Sloan Kettering Monmouth (Limited Protocol Activities)Recruiting
  • Memorial Sloan Kettering Bergen (Limited Protocol Activities)Recruiting
  • Memorial Sloan Kettering Cancer Center @ Suffolk - Commack (Limited Protocol Activities)Recruiting
  • Memorial Sloan Kettering Westchester (Limited Protocol Activities)Recruiting
  • Memorial Sloan Kettering Cancer Center (All Protocol Activities)Recruiting
  • Memorial Sloan Kettering Nassau (Limited Protocol Activities)Recruiting
  • Jefferson Abington Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Arm A

Arm B

Arm Description

Randomized to standard technique and assessment of anastomosis without the use of NIR angiography

Randomized to additional assessment of proximal colonic stump and anastomotic perfusion using NIR angiography

Outcomes

Primary Outcome Measures

Reduction of the risk of 30-day postoperative anastomotic leak at the site of rectosigmoid resection, compared with standard intraoperative assessment alone
To determine whether the use of NIR angiography assessment of perfusion at the time of rectosigmoid resection in a cohort of patients undergoing surgery for ovarian cancer reduces the risk of 30-day postoperative anastomotic leak at the site of rectosigmoid resection, compared with standard intraoperative assessment alone.

Secondary Outcome Measures

Full Information

First Posted
May 4, 2021
Last Updated
August 8, 2023
Sponsor
Memorial Sloan Kettering Cancer Center
search

1. Study Identification

Unique Protocol Identification Number
NCT04878094
Brief Title
A Study of Intra-operative Imaging in Women With Ovarian Cancer
Official Title
ARIA II: A Phase III Randomized Controlled Trial of Near-Infrared Angiography During Rectosigmoid Resection and Anastomosis in Women With Ovarian Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 3, 2021 (Actual)
Primary Completion Date
May 3, 2025 (Anticipated)
Study Completion Date
May 3, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Memorial Sloan Kettering Cancer Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes

5. Study Description

Brief Summary
The purpose of this study is to find out whether using the PINPOINT imaging system intra-operatively can reduce the risk of anastomotic leaks and other complications after surgery for ovarian cancer, compared with standard intra-operative assessments alone. The PINPOINT endoscopic fluorescence imaging system uses a special camera and a fluorescent (glowing) dye that can evaluate the blood flow of the bowel in real-time. If there is an area that appears concerning, the surgeon can correct the problem during the procedure.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ovarian Cancer, Ovarian Carcinoma
Keywords
Ovarian cancer, PINPOINT, rectosigmoid resection, anastomosis, 21-202, Memorial Sloan Kettering Cancer Center

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
310 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Arm A
Arm Type
Active Comparator
Arm Description
Randomized to standard technique and assessment of anastomosis without the use of NIR angiography
Arm Title
Arm B
Arm Type
Experimental
Arm Description
Randomized to additional assessment of proximal colonic stump and anastomotic perfusion using NIR angiography
Intervention Type
Diagnostic Test
Intervention Name(s)
Intravenous Indocyanine Green/ICG injection
Intervention Description
Intravenous Indocyanine Green/ICG injection will be administered for visualization
Intervention Type
Diagnostic Test
Intervention Name(s)
PINPOINT endoscopic fluorescence imaging system
Intervention Description
After resection the surgeon will use the PINPOINT imaging system to assess perfusion of the colonic stump. The intervention will again be used following establishment of the anastomosis, however this time via a proctoscope to visualize the proximal and distal ends of the rectosigmoid anastomosis.
Intervention Type
Diagnostic Test
Intervention Name(s)
Endoscopy
Intervention Description
Standard technique and assessment of anastomosis without the use of NIR angiography
Primary Outcome Measure Information:
Title
Reduction of the risk of 30-day postoperative anastomotic leak at the site of rectosigmoid resection, compared with standard intraoperative assessment alone
Description
To determine whether the use of NIR angiography assessment of perfusion at the time of rectosigmoid resection in a cohort of patients undergoing surgery for ovarian cancer reduces the risk of 30-day postoperative anastomotic leak at the site of rectosigmoid resection, compared with standard intraoperative assessment alone.
Time Frame
45 days post procedure

10. Eligibility

Sex
Female
Accepts Healthy Volunteers
No
Eligibility Criteria
Participant Inclusion Criteria Part 1 (pre-operative): Diagnosed with primary or recurrent ovarian, fallopian tube, or primary peritoneal cancer Scheduled to undergo debulking or cytoreductive surgery Suspected need for a low anterior rectosigmoid resection at the time of a debulking procedure Enrolled and consented before the operation Part 2 (intra-operative): Completed rectosigmoid resection Surgeon plans to perform colorectal anastomosis Participant Exclusion Criteria Part 1 (pre-operative): Documented history of allergic reaction to ICG Not approached for study enrollment before undergoing an unexpected low anterior rectosigmoid resection Part 2 (intra-operative): Did not undergo rectosigmoid resection intraoperatively Surgical procedure with rectosigmoid resection for any other type of gynecologic malignancy Patient requires permanent colostomy
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mario Leitao, MD
Phone
212-639-3987
Email
leitaom@mskcc.org
First Name & Middle Initial & Last Name or Official Title & Degree
Dennis Chi, MD
Phone
212-639-5016
Email
chid@mskcc.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mario Leitao, MD
Organizational Affiliation
Memorial Sloan Kettering Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)
City
Basking Ridge
State/Province
New Jersey
ZIP/Postal Code
07920
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mario Leitao, MD
Phone
212-639-3987
Facility Name
Memorial Sloan Kettering Monmouth (Limited Protocol Activities)
City
Middletown
State/Province
New Jersey
ZIP/Postal Code
07748
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mario Leitao, MD
Phone
212-639-3987
Facility Name
Memorial Sloan Kettering Bergen (Limited Protocol Activities)
City
Montvale
State/Province
New Jersey
ZIP/Postal Code
07645
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mario Leitao, MD
Phone
212-639-3987
Facility Name
Memorial Sloan Kettering Cancer Center @ Suffolk - Commack (Limited Protocol Activities)
City
Commack
State/Province
New York
ZIP/Postal Code
11725
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mario Leitao, MD
Phone
212-639-3987
Facility Name
Memorial Sloan Kettering Westchester (Limited Protocol Activities)
City
Harrison
State/Province
New York
ZIP/Postal Code
10604
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mario Leitao, MD
Phone
212-639-3987
Facility Name
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mario Leitao, MD
Phone
212-639-3987
Facility Name
Memorial Sloan Kettering Nassau (Limited Protocol Activities)
City
Uniondale
State/Province
New York
ZIP/Postal Code
11553
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mario Leitao, MD
Phone
212-639-3987
Facility Name
Jefferson Abington Hospital
City
Willow Grove
State/Province
Pennsylvania
ZIP/Postal Code
19090
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Leah Moukarzel, MD
Phone
215-481-4000

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.
Links:
URL
http://www.mskcc.org
Description
Memorial Sloan Kettering Cancer Center

Learn more about this trial

A Study of Intra-operative Imaging in Women With Ovarian Cancer

We'll reach out to this number within 24 hrs