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Trial record 1 of 1 for:    NCT03683550
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Comparing SLNE With or Without Preoperative Hybrid SPECT/CT in Melanoma

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ClinicalTrials.gov Identifier: NCT03683550
Recruitment Status : Recruiting
First Posted : September 25, 2018
Last Update Posted : December 7, 2018
Sponsor:
Information provided by (Responsible Party):
Dr. Joachim Klode, University Hospital, Essen

Brief Summary:

Melanoma has become a growing interdisciplinary problem in public health worldwide. It characteristically disseminates in an orderly progression through lymphatic channels to the regional lymph node and then to more distant sites.

Sentinel lymph node excision (SLNE) is probably the most important diagnostic and potentially therapeutic procedure for melanoma patients.

This is a randomized, open-label, multi-center, superiority, 2-parallel arms trial comparing sentinel lymph node excision with or without preoperative hybrid single photon emission computed tomography/computed tomography in patients with malignant melanoma.


Condition or disease Intervention/treatment Phase
Melanoma Procedure: SLNE with preoperative hybrid SPECT/CT Procedure: Standard SLNE Not Applicable

Detailed Description:

The presence of regional lymph node involvement is the single most important prognostic factor, lowering the 5-year survival rate to approximately 50%.

Recommendations for the use of SLNE for primary melanoma are included in the current American Joint Committee on Cancer guidelines. Critics argue that the routinely performed SLNE is a cost intensive surgical intervention with potential morbidity that does not offer patients any advantage in overall survival. The current gold standard for detection and targeted extirpation of the sentinel lymph node (SLN) is preoperative lymphoscintigraphy as an imaging technique to identify the lymph drainage basin, determine the number of sentinel nodes, differentiate sentinel nodes from subsequent nodes, locate the sentinel node in an unexpected location, and mark the sentinel node over the skin for biopsy. Single-photon emission computed tomography/computed tomography (SPECT/CT) provides complementary functional and anatomical information and has been shown to be superior to planar imaging in a number of indications. It can provide valuable information before sentinel lymph node biopsy and advocate its use in a range of tumors such as truncal and head and neck melanomas.

The objective of the planned multi-center randomized prospective trial is to compare distant metastasis-free survival (DMFS) in patients with cutaneous melanoma between sentinel lymph node excision with versus without preoperative SPECT/CT imaging and metastatic node detection.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 836 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized Trial Comparing Sentinel Lymph Node Excision (SLNE) With or Without Preoperative Hybrid Single-photon Emission Computed Tomography/Computed Tomography (SPECT/CT) in Melanoma
Actual Study Start Date : September 25, 2018
Estimated Primary Completion Date : September 2021
Estimated Study Completion Date : September 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Melanoma

Arm Intervention/treatment
Experimental: SPEC/CT
SLNE with preoperative hybrid SPECT/CT
Procedure: SLNE with preoperative hybrid SPECT/CT
Single-photon emission computed tomography/computed tomography (SPECT/CT) provides complementary functional and anatomical information and has been shown to be superior to planar imaging in a number of indications. It can provide valuable information before sentinel lymph node biopsy and advocate its use in a range of tumors such as truncal and head and neck melanomas.

Active Comparator: Standard
Standard SLNE (with planar preoperative lymphoscintigraphy)
Procedure: Standard SLNE

The current gold standard for detection and targeted extirpation of the sentinel lymph node (SLN) is preoperative lymphoscintigraphy.

Lymphoscintigraphy (sentinel lymph node mapping) is an imaging technique used to identify the lymph drainage basin, determine the number of sentinel nodes, differentiate sentinel nodes from subsequent nodes, locate the sentinel node in an unexpected location, and mark the sentinel node over the skin for biopsy.





Primary Outcome Measures :
  1. Distant free metastasis survival (DFMS) [ Time Frame: 6 years ]
    The number of patients free of distant metastasis after randomization in arm A compared to DFMS in arm B.


Secondary Outcome Measures :
  1. Overall survival (OS) [ Time Frame: 6 years ]
    Overall Survival (OS) of a patient defined as the time frame start of run-in phase until documented date of death

  2. Disease-free survival (DFS) [ Time Frame: 6 years ]
    The number of patients alive and free of disease after randomization in arm A compared to DFS in arm B.

  3. False negative rate of SLN [ Time Frame: 3 years ]
    Rate of local relapse within a 12 month follow-up period (false negative rate of sentinel lymph nodes [SLN])

  4. Sensitivity [ Time Frame: 3 years ]
    Number of positive SLN

  5. Complication rate [ Time Frame: 6 years ]
    Intraoperative and postoperative complications due to SLNE

  6. Quality of Life (QoL) [ Time Frame: 6 years ]
    Measure of health outcome by questionnaire. The EuroQol-5 Dimensions-5 Level (EQ-5D-5L) questionnaire consists of five HrQoL dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression), with each dimension specifying five levels of severity [no (level 1), slight (level 2), moderate (level 3), severe (level 4), and extreme problems/unable (level 5)], which allows the description of 3125 health states.

  7. Quality adjusted life years (QALY) [ Time Frame: 6 years ]
    Assessing the health economic relevance

  8. Number of inpatient days [ Time Frame: 6 years ]
    To calculate the cost of the two treatment options the number of inpatient days will be counted and compared for each treatment arm.

  9. Overall costs during hospital stays [ Time Frame: 6 years ]
    Overall costs during hospital stays will be summed up and compared.

  10. Incidence of Treatment-Emergent Adverse Events [ Time Frame: 6 years ]
    Intervention-related safety events will be documented during the trial period



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with malignant melanoma in AJCC stages Ib / II
  • Tumor depth of ≥1.0 mm
  • Age ≥18 years to ≤75 years
  • Have a primary melanoma that is cutaneous (including head, neck, trunk, extremity, scalp, palm, sole, subungual skin tissues
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-1
  • Life expectancy of at least 5 years from the time of diagnosis, not considering the melanoma in question, as determined by the principal investigator (PI)
  • Willing to return to the trial center for follow-up examinations and procedures as outlined in the protocol
  • Randomization must be completed no more than 120 days following the diagnostic biopsy of the primary melanoma
  • Negative pregnancy test for female and effective contraception for both male and female subjects if the risk of conception exists
  • Signed written informed consent prior to the performance of any trial specific procedure

Exclusion Criteria:

  • History of previous or concurrent (i.e., second primary) invasive melanoma
  • Primary melanoma of the eye, mucous membranes or internal viscera
  • Any additional solid tumor or hematologic malignancy during the past 5 years except skin lesions of squamous cell carcinoma, basal cell carcinoma, or uterine cervical cancer
  • Skin grafts, tissue transfers or flaps that have the potential to alter the lymphatic drainage pattern from the primary melanoma to a lymph node basin
  • Hypersensitivity to the active substance(s), to any of the excipients or to any of the components of the labelled radiopharmaceutical
  • Extensive previous surgery in the region of the primary tumor site or complete lymph node dissection (CLNDs) or sentinel lymphadenectomy (SLs) (before evaluation of the current melanoma) that may have altered the lymphatic drainage pattern from the primary cutaneous melanoma to a potential lymph node basin
  • Organic brain syndrome or significant impairment of basal cognitive function or any psychiatric disorder that might preclude participation in the full protocol, or be exacerbated by therapy (e.g., severe depression)
  • Pregnancy (absence to be confirmed by ß-human chorionic gonadotropin test) or lactation period
  • Medical or psychological conditions that would not permit the subject to complete the study or sign informed consent
  • Known alcohol or drug abuse
  • Participation in another clinical study within the 30 days before registration
  • Significant disease which, in the investigator's opinion, would exclude the patient from the study
  • Legal incapacity or limited legal capacity

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): NCT03683550


Contacts
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Contact: Joachim Klode, MD +492017231812 joachim.klode@uk-essen.de
Contact: Ingo Stoffels, MD +492017234756 ingo.stoffels@uk-essen.de

Locations
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Germany
Medizinische Hochschule Hannover Not yet recruiting
Hannover, Niedersachsen, Germany, 30625
Contact: Ralf Gutzmer, MD       gutzmer.ralf@mh-hannover.de   
Principal Investigator: Ralf Gutzmer, MD         
Department of Dermatology, University Hospital Essen Recruiting
Essen, NRW, Germany, 45122
Contact: Joachim Klode, MD         
Contact: Ingo Stoffels, MD         
Principal Investigator: Joachim Klode, MD         
Principal Investigator: Ingo Stoffels, MD         
Hospital Augsburg, Department of Dermatology Not yet recruiting
Augsburg, Germany, 86156
Contact: Welzel Julia, Prof. Dr.       derma@klinikum-augsburg.de   
Vivantes Hospital Berlin Neukölln Not yet recruiting
Berlin, Germany, 12351
Contact: Uwe Hillen, Prof. Dr.       uwe.hillen@vivantes.de   
Hospital Dresden Friedrichstadt, Department of Dermatology and Allergology Not yet recruiting
Dresden, Germany, 01067
Contact: Uwe Wollina, Prof. Dr.       Wollina-Uw@khdf.de   
University Hospital Göttingen, Department of Dermatology Not yet recruiting
Göttingen, Germany, 37075
Contact: Lutz Kretschmer, Prof. Dr.       lkre@med.uni-goettingen.de   
University Hospital Heidelberg, Department of Dermatology Not yet recruiting
Heidelberg, Germany, 69120
Contact: Patrick Gholam, Dr.       Patrick.Gholam@med.uni-heidelberg.de   
University Hospital Lübeck, Department of Dermatology Not yet recruiting
Lübeck, Germany, 23538
Contact: Birgit Kahle, Prof. Dr.       Birgit.Kahle@uksh.de   
Sponsors and Collaborators
University Hospital, Essen
Investigators
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Principal Investigator: Ingo Stoffels, MD Department of Dermatology, University Hospital Essen
Principal Investigator: Joachim Klode, MD Department of Dermatology, University Hospital Essen

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Dr. Joachim Klode, Prof. Dr. med, University Hospital, Essen
ClinicalTrials.gov Identifier: NCT03683550     History of Changes
Other Study ID Numbers: SNEPS 2018
First Posted: September 25, 2018    Key Record Dates
Last Update Posted: December 7, 2018
Last Verified: December 2018

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

Keywords provided by Dr. Joachim Klode, University Hospital, Essen:
SLNE
SPECT/CT

Additional relevant MeSH terms:
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Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas