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Laser Fluorescence in Cancer Surgical Treatment

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ClinicalTrials.gov Identifier: NCT03021200
Recruitment Status : Recruiting
First Posted : January 13, 2017
Last Update Posted : November 12, 2019
Sponsor:
Collaborators:
Ministério da Saúde
Fundação Faculdade de Medicina
Information provided by (Responsible Party):
Instituto do Cancer do Estado de São Paulo

Brief Summary:

The use of fluorescence for real-time evaluation of organ and tissue vascularization and lymph node anatomy is a recent technology with potential for the surgical treatment of cancer. The real-time analysis of tissue vascularization allows immediate identification to the surgeon of areas with greater or lesser blood circulation, favoring surgical decision making and prevention of complications related to tissue ischemia (necrosis, dehiscences and infections). It is a technology with potential application in the areas of Digestive Surgery, Repairing Plastic Surgery in Oncology, Head and Neck Surgery. In addition, fluorescence can be used as a method to identify lymph node structures of interest in the oncological treatment of patients with urologic, gynecological and digestive tumors.

Introduced by Pestana et al. In the late 2000s, the perfusion mapping system through intraoperative indocyanine assisted laser angiography (SPY Elite System © LifeCell Corp., Branchburg, N.J.) had its initial application in repairing surgery after breast cancer treatment. The method proved to be useful in the prevention of ischemic and infectious complications in cancer surgery. Pestana, in a prospective clinical series of 29 microsurgical flaps used in several reconstructions, observed a single case of partial loss of the flap, the present technology having a relevant role in intraoperative decision making. In the same year, Newman et al. The first application of the system in breast reconstruction surgery. In an initial series of 10 consecutive cases of reconstruction with microsurgical flaps, in 4 cases the system allowed the intraoperative identification of areas of low perfusion, thus changing the surgical procedure. According to the authors, there was a 95% correlation between indocyanine laser assisted and subsequent development of mastectomy skin necrosis, with sensitivity of 100% and specificity of 91%. Similarly, Murray et al. Evaluated the intraoperative perfusion, however, of the areola-papillary complex in patients submitted to subcutaneous mastectomies with satisfactory results in terms of predictability of cutaneous circulation. Other authors in larger clinical series and evaluating other procedures have observed valid results in terms of prevention of complications.

Vascular perfusion of anastomoses and fistulas following bowel surgery for cancer remain a serious and common complication. These fistulas can be caused by insufficient perfusion of the intestinal anastomosis. Intraoperative angiography with indocyanine assisted laser can be used to visualize the blood perfusion following intravenous injection of the indocyanine green contrast. Several groups reported the ability to assess blood perfusion of the anastomotic area after bowel surgery. Although they studied retrospectively, Kudszus and colleagues described a reduction in the risk of revision due to fistula in 60% of patients whose anastomosis was examined using laser fluorescence angiography compared to historically paired patients without this method. The same principle can be used to evaluate the tubulized stomach to be transposed to the cervical region after subtotal esophagectomy.

Currently, fluorescence-guided sentinel lymph node mapping has been studied in breast cancer as well as investigative character in colorectal cancer, skin cancer, cervical cancer, vulvar cancer, head and neck, lung cancer, penile cancer, cancer Endometrial cancer, gastric cancer and esophageal cancer.

These early studies demonstrated the feasibility of this methodology during surgery. Comparison of laser fluorescence images on blue dyes indicate that fluorescence images can replace blue dyes because they exceed them due to increased tissue penetration depth and absence of staining in the patient and cleaning of the operative field.

To date, there are no clinical studies involving intraoperative perfusion mapping and identification of lymph node structures with the SPY Elite System © system or other platforms (Pinpoint or Firefly) in Brazil that evaluate the Brazilian population. In an objective way the influence of this technology as predictive in the better or worse evolution of the oncologic surgery as well as in the prevention of the local ischemic complications by means of intraopeal change of conduct


Condition or disease Intervention/treatment Phase
Esophageal Cancer Gastric Cancer ColoRectal Cancer Prostatic Neoplasms Uterine Cancer Head and Neck Cancer Breast Neoplasm Device: Green indocianine Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 270 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Use of Laser Fluorescence With Spy Elite, Pinpoint and Firefly Robotic Platform Systems in Cancer Surgical Treatment
Actual Study Start Date : July 12, 2016
Actual Primary Completion Date : October 12, 2017
Estimated Study Completion Date : December 10, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Indocyanine green in Conventional Oncological Surgery
Use of indocyanine green laser fluorescence angiography (AFLIICG) platforms (SPY-Elite) for conventional oncological surgeries
Device: Green indocianine
Laser fluorescence using green indocianine guiding the surgical procedure.

Experimental: Indocyanine green in minimally invasive Oncological Surgery
Use of indocyanine green laser fluorescence angiography (AFLIICG) platforms (Pinpoint) for minimally invasive oncological surgeries
Device: Green indocianine
Laser fluorescence using green indocianine guiding the surgical procedure.

Experimental: Indocyanine green in robot-assisted Oncological Surgery
Use of indocyanine green laser fluorescence angiography (AFLIICG) platforms (Firefly) for robot-assisted oncological surgeries
Device: Green indocianine
Laser fluorescence using green indocianine guiding the surgical procedure.




Primary Outcome Measures :
  1. Intestinal Anastomosis Fistula [ Time Frame: 3 years ]
    Intestinal Anastomosis Fistula Rate in oncologic resection of intestinal tumors

  2. Esophageal fistula [ Time Frame: 3 years ]
    Esophageal reconstruction fistula rate in esophagectomies

  3. positive lymph nodes [ Time Frame: 3 years ]
    The number of fluorescence-positive lymph nodes per patient

  4. lymph nodes detected by pathology [ Time Frame: 3 years ]
    The number of lymph nodes detected by pathology per patient

  5. Mastectomy Skin Necrosis [ Time Frame: 3 years ]
    Mastectomy Skin Necrosis Rate in Breast Reconstructions

  6. Breast Implant Extrusion [ Time Frame: 3 years ]
    Breast Implant Extrusion Rate in Breast Reconstructions

  7. Surgical Site Infection in Breast Reconstructions [ Time Frame: 3 years ]
    Surgical Site Infection Rate in Breast Reconstructions

  8. Skin Necrosis in Head and Neck Reconstruction [ Time Frame: 3 years ]
    Skin Necrosis Rate in Supraclavicular snip in Head and Neck Reconstruction



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with cancer and indication for one of the following surgeries:
  • Low Anterior Resection
  • Esophagectomy
  • Lymphadenectomy
  • Prostatectomy
  • Pelvic or paraortic lymphadenectomy
  • Surgery of head and neck with indication of supraclavicular flap
  • Mastectomy followed by immediate or late breast reconstruction

Exclusion Criteria:

  • Patients with a history of adverse reaction or known allergy to contrast, or iodine tinctures;
  • Pregnant or lactating women.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03021200


Contacts
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Contact: Ulysses Ribeiro, MD 55 11 3893-2574 ulysses.ribeiro@fm.usp.br
Contact: Evelise P Zaidan 55 11 3893-3546 evelize.zaidan@hc.fm.usp.br

Locations
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Brazil
Ulysses Ribeiro Junior Recruiting
Sao Paulo, São Paulo, Brazil, 01246-000
Contact: Evelise P Zaidan    55 11 38933546    evelise.zaidan@hc.usp.br   
Sub-Investigator: Marcus FKP Ramos, MD         
Sponsors and Collaborators
Instituto do Cancer do Estado de São Paulo
Ministério da Saúde
Fundação Faculdade de Medicina
Investigators
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Principal Investigator: Ulysses Ribeiro, MD Instituto do Cancer do Estado de Sao Paulo

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Responsible Party: Instituto do Cancer do Estado de São Paulo
ClinicalTrials.gov Identifier: NCT03021200    
Other Study ID Numbers: NP953/16
First Posted: January 13, 2017    Key Record Dates
Last Update Posted: November 12, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Breast Neoplasms
Prostatic Neoplasms
Uterine Neoplasms
Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Genital Neoplasms, Male
Urogenital Neoplasms
Genital Diseases, Male
Prostatic Diseases
Genital Neoplasms, Female
Uterine Diseases
Genital Diseases, Female