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Use of Indocyanine Green During Pelvic Lymph Node Dissection in Prostate Cancer.

Primary Purpose

Prostate Cancer, Lymph Node Metastases

Status
Unknown status
Phase
Phase 4
Locations
Turkey
Study Type
Interventional
Intervention
Indocyanine green
Sponsored by
TC Erciyes University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Cancer focused on measuring indocyanine green based fluorescence imaging, extendend lymph node dissection, prostate cancer

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)MaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Histologically confirmed locally limited prostate cancer;
  • Intermediate or high risk tumor
  • Recommended and planned prostatectomy;
  • Completed and signed written consent;
  • Voluntarily agreement to participate in this study
  • Age of the study participants ≥ 18 years.

Exclusion Criteria:

  • Allergic reaction to active ingredient (indocyanine green);
  • Iodine allergy;
  • Hyperthyroidism;
  • High-grade renal impairment;
  • High-grade hepatic insufficiency;
  • Unwillingness to the storage and disclosure of pseudonymous disease and personal data
  • psychiatric pre-existing conditions or other circumstances that make a cooperation by the patient in question

Sites / Locations

  • Department of Urology, Ercieys University, Faculty Of Medicine,Recruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

ICG group

Arm Description

ICG injection before LRRP via cystoscopy

Outcomes

Primary Outcome Measures

Indocyanine green postive lymph node numbers
total number of dissected lymph nodes which are indocyanine green positive
Total lymph node numbers of conventional extended lymph node dissection
total number of dissected lymph nodes during conventional extended lymph node dissection
pathology of indocyanine green positive lymph nodes
İndocyanine green positvie lymph nodes are malign or benign
pathology of lymph nodes
Pathology of material from conventional extended lymph node dissection

Secondary Outcome Measures

Full Information

First Posted
January 31, 2021
Last Updated
May 8, 2021
Sponsor
TC Erciyes University
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1. Study Identification

Unique Protocol Identification Number
NCT04882618
Brief Title
Use of Indocyanine Green During Pelvic Lymph Node Dissection in Prostate Cancer.
Official Title
Is the Extended Lymph Node Dissection Under Indocyanine Green (ICG) Based Fluorescence Imaging Superior to Conventional Extended Lymph Node Dissection During Laparoscopic Radical Prostatectomy(LRRP)?
Study Type
Interventional

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Unknown status
Study Start Date
November 8, 2019 (Actual)
Primary Completion Date
November 8, 2021 (Anticipated)
Study Completion Date
November 8, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
TC Erciyes University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Standard treatment of local or locally advanced prostate cancer is radical prostatectomy (RRP) surgery. During RRP in certain patients extended lymph node dissection (ELND) is recommended. to detect eligible patients for ELND some nomograms based on clinical factors of them is used. The Briganti nomogram is one of them. If the patient has 7% or more probability on Briganti nomogram, then ELND is recommended. But ELND is complicated surgical procedure and may cause labor lost and cost. It is aimed here to show whether the ICG based fluorescence imaging during laparoscopy may yield higher accuracy to detect metastatic LNs than the conventional ELND?
Detailed Description
50 patients with diagnosis of local or locally advance prostate cancer and having LN invasion probability between 7-50% on 2018 Briganti Nomogram will be included to this study. Before Laparoscopic radical prostatectomy (LRRP), ICG is injected left and right lobe of the propagate during cystoscopy. Extended LND is performed in all patients. But before it, fluorescence imaging will be done, and ICG positive lymph nodes (LN) are dissected and sent pathology separately. Positive LN yield pf ICG guided LND and conventional LND is compared.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer, Lymph Node Metastases
Keywords
indocyanine green based fluorescence imaging, extendend lymph node dissection, prostate cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Model Description
Prospective single arm study
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
ICG group
Arm Type
Experimental
Arm Description
ICG injection before LRRP via cystoscopy
Intervention Type
Drug
Intervention Name(s)
Indocyanine green
Other Intervention Name(s)
Conventional ELND
Intervention Description
indocyanine green application during LRRP to detect positive lymph nodes. ICG will be injected to prostate lobes via csytoscopy
Primary Outcome Measure Information:
Title
Indocyanine green postive lymph node numbers
Description
total number of dissected lymph nodes which are indocyanine green positive
Time Frame
15 day after surgery
Title
Total lymph node numbers of conventional extended lymph node dissection
Description
total number of dissected lymph nodes during conventional extended lymph node dissection
Time Frame
15 day after surgery
Title
pathology of indocyanine green positive lymph nodes
Description
İndocyanine green positvie lymph nodes are malign or benign
Time Frame
15 day after surgery
Title
pathology of lymph nodes
Description
Pathology of material from conventional extended lymph node dissection
Time Frame
15 day after surgery

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Histologically confirmed locally limited prostate cancer; Intermediate or high risk tumor Recommended and planned prostatectomy; Completed and signed written consent; Voluntarily agreement to participate in this study Age of the study participants ≥ 18 years. Exclusion Criteria: Allergic reaction to active ingredient (indocyanine green); Iodine allergy; Hyperthyroidism; High-grade renal impairment; High-grade hepatic insufficiency; Unwillingness to the storage and disclosure of pseudonymous disease and personal data psychiatric pre-existing conditions or other circumstances that make a cooperation by the patient in question
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Abdullah A Demirtaş, MD, PRof
Phone
+905325094494
Email
mesane@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Şevket TOLGA T Tombul, MD
Phone
05364774525
Email
sevkettolgatombul@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Abdullah A Demirtaş, Md, Prof
Organizational Affiliation
TC Erciyes University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Urology, Ercieys University, Faculty Of Medicine,
City
Kayseri
ZIP/Postal Code
38039
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Abdullah Demirtas, MD
Phone
+905325094494
Email
mesane@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Use of Indocyanine Green During Pelvic Lymph Node Dissection in Prostate Cancer.

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