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Mapping Sentinel Lymph Node in Initial Stages of Ovarian Cancer (MELISA)

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ClinicalTrials.gov Identifier: NCT05184140
Recruitment Status : Recruiting
First Posted : January 11, 2022
Last Update Posted : March 29, 2022
Sponsor:
Information provided by (Responsible Party):
Núria Agustí, Hospital Clinic of Barcelona

Brief Summary:

Epithelial ovarian cancer (EOC) diagnosed in the initial stage (stage I-II) require complete staging surgery to histologically assess the possible existence of peritoneal or lymph node disease.

Systematic pelvic and paraaortic lymphadenectomy in stage I-II EOC is essential since confirming the presence of lymph node metastases means re-staging the disease as stage III. This change of stage has important prognostic and therapeutic implications. However, the lymph node involvement rate is around 10-30% (average of 15%). Systematic pelvic and para-aortic lymphadenectomy carries a risk of intraoperative complications, as well as longer operative time, postoperative complications and longer hospital stay. Moreover, by now there is no evidence suggesting a possible therapeutic value.

The sentinel lymph node (SLN) detects the first level of lymph node drainage. The absence of metastases in the SLN predicts the absence of tumor infiltration of the rest of lymph nodes of the same anatomical region and allows to safely avoid lymphadenectomy and its associated morbidity. In addition, the exhaustive evaluation of the SLN by ultrastaging and immunohistochemical study allows to increase the detection of microscopic disease.

Sentinel lymph node (SLN) biopsy, implemented in clinical practice in other gynecological tumors (breast, vulva, cervix or endometrium), has been studied very little in the initial ovarian epithelial cancer. Unlike other gynecological tumors, there are multiple anatomical and technical aspects that largely explain this lack of information. The double ovarian vascularization that accompanies lymphatic drainage explains this higher complexity. Therefore, at the present time, the detection of SLN in the initial EOC remains an experimental area without applicability in clinical practice. There are multiple doubts and issues to be resolved regarding the different tracers, the site and time injection and the actual accuracy of the SLN versus the lymphadenectomy.


Condition or disease Intervention/treatment Phase
Ovarian Cancer Sentinel Lymph Node Procedure: Sentinel node detection Not Applicable

Detailed Description:

The objective of this study is to know the lymphatic drainage and, if the lesion is malignant, remove the sentinel lymph nodes to know if it can predict the involvement of the remaining lymph nodes to assess the possible applicability of SLN in clinical practice.

Study design:

  1. Evaluation of the ovarian lymphatic map: injection of radiotracer (99mTc-nanocolloid albumin) in patients with a diagnosis of adnexal mass with high suspicion of malignancy. Intraoperative lymphogammagraphy will be performed using a portable gammacamera. Patients with a delayed diagnosis of ovarian cancer who are candidates to undergo a re-staging surgery will be included.
  2. After the adnexectomy a frozen section will be performed to confirm the diagnosis of malignancy and then the ICG (Indocyanine green) tracer will be injected. Since the spread and persistence of the ICG in the lymph nodes is rapid, this tracer will be injected only after confirmation of EOC. Simultaneous screening with a gammadetector probe and NIR (near-infrared spectrum) camera will be used to proceed to the detection of SLN according to the lymphatic map previously.
  3. Ultrastaging of the SLN by applying hematoxylin and eosin staining (H&E) and, in the absence of metastatic disease, evaluation by immunohistochemistry with cytokeratin AE1: AE3.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 62 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Controlled, prospective, descriptive
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: MELISA Trial: Mapping sEntinel Lymph Node in Initial StAges of Ovarian Cancer
Actual Study Start Date : January 1, 2021
Estimated Primary Completion Date : January 1, 2023
Estimated Study Completion Date : January 1, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ovarian Cancer

Arm Intervention/treatment
Experimental: Adnexal mass with high suspicion of malignancy
An ovarian lymphatic map will be performed in patients with adnexal masses suspected of malignancy. Sentinel node exeresis and a complete staging surgery (including pelvic and para-aortic lymphadenectomy) will be performed in patients with ovarian cancer confirmation including restaging surgeries.
Procedure: Sentinel node detection

Injection of the radiotracer to infundibulo-pelvic and utero-ovarian ligament in patients with high suspicion of malignancy adnexal mass. Injection of green indocyanine r to infundibulo-pelvic and utero-ovarian stumps only in case of malignancy after the adnexectomy.

Sentinel node exeresis and a complete staging surgery (including pelvic and para-aortic lymphadenectomy) will be performed in patients with ovarian cancer diagnosis.

Other Name: Complete staging surgery




Primary Outcome Measures :
  1. Detection rate of sentinel node technique [ Time Frame: Through study completion, an average of 2 years ]
    Detection of SLN in initial epithelial ovarian cancer by assessing the concordance of the result between the lymph node metastases and the lymphadenectomy


Secondary Outcome Measures :
  1. Tracer specific detection rate [ Time Frame: 2 years ]
    To know the global and specific SLN identification rate, depending on the type of tracer used.

  2. Tracer-related adverse events [ Time Frame: 1 month ]
    The number of patients with tracer-related adverse events

  3. False negative rate and negative predictive value [ Time Frame: 2 years ]
    Evaluate the existence of false negatives in metastatic involvement of the SLN and negative predictive value

  4. Anatomical location of the sentinel lymph node [ Time Frame: 2 years ]
    The aortic and pelvic region will be divided 13 regions

  5. Detection rate of gamma-camera, gamma-probe and Infrared fluorescence camera [ Time Frame: 2 years ]
    Evaluate the performance of intraoperative lymphoscintigraphy with gamma-camera, gamma-probe and Infrared fluorescence camera in the visualization of the ovarian lymphatic map.

  6. Surgical time extension performing SLN technique [ Time Frame: 2 years ]
    Evaluate the time it takes to perform the SLN technique

  7. Anatomopathological ultrastaging examination of the sentinel lymph node [ Time Frame: 2 years ]
    Evaluate if ultrastaging of the SLN improves the detection of micrometastases compared to conventional histology. Ultrastaging protocol will be performed, consisting of two consecutive histological sections (4 μm thick) obtained at regular intervals of 150 μm, performing 4 levels of each paraffin block. The first section will be stained with H&E and the second section will be stained immunohistochemically with an AE1-AE3 anti-keratin antibody (Dako®).


Other Outcome Measures:
  1. Evaluation of sentinel lymph node technique [ Time Frame: Through study completion, an average of 2 years ]
    To check the ovarian lymphatic drainage in patients with suspected malignant adnexal masses



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:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Patients with a diagnosis of adnexal mass with high suspicion of malignancy and frozen section examination will undergo the lymphatic map with a radiotracer.
  • Patients with intraoperative diagnosis of epithelial ovarian cancer will undergo the SLN exeresis with two tracers.
  • Patients with a delayed diagnosis of epithelial ovarian cancer who are candidates to undergo a re-staging surgery will undergo the SLN exeresis with two tracers.

Exclusion Criteria:

  • Advanced ovarian cancer (FIGO III/IV)
  • Patients <18 years
  • Pregnancy or lactation
  • Previous vascular surgery (cava, aorta, iliac vessels), lymphadenectomy (pelvic or paraortic) or radiotherapy (pelvic or paraortic field)
  • Severe adherent syndrome that prevents tracer injection
  • The SLN technique will not be performed in case of benign ovarian tumor in the frozen section or borderline tumor (since in these cases there is no clinical indication of performing a lymphadenectomy)
  • Non-operable patient
  • Previous adverse events to the radiotracer or ICG

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): NCT05184140


Contacts
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Contact: Núria Agustí, MD +34 932 27 54 00 ext 5334 nagusti@clinic.cat
Contact: Pilar Paredes, PhD pparedes@clinic.cat

Locations
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Spain
Núria Agustí Garcia Recruiting
Barcelona, Spain, 08014
Contact: Núria Agustí Garcia, MD    +34627654987    nagusti@clinic.cat   
Sponsors and Collaborators
Hospital Clinic of Barcelona
Investigators
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Study Director: Aureli Torné, PhD Hospital Clinic of Barcelona
Study Director: Berta Díaz-Feijóo, PhD Hospital Clinic of Barcelona
Additional Information:
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Responsible Party: Núria Agustí, Principal Investigator, Hospital Clinic of Barcelona
ClinicalTrials.gov Identifier: NCT05184140    
Other Study ID Numbers: HCB/2021/0130
First Posted: January 11, 2022    Key Record Dates
Last Update Posted: March 29, 2022
Last Verified: March 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: The IPD will be shared only with those making official request to the study investigator
Supporting Materials: Study Protocol
Informed Consent Form (ICF)
Time Frame: The data will become available One year after publication, and they will be available for 6 months.
Access Criteria: Direct request to the study PI

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Núria Agustí, Hospital Clinic of Barcelona:
Ovarian Cancer
Sentinel Lymph Node
Additional relevant MeSH terms:
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Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type