Comparing SLNE With or Without Preoperative Hybrid SPECT/CT in Melanoma

NCT03683550 | Unknown DMC

• 1 other identifier: SNEPS 2018
• Study Type: interventional
• Target: 836
• Locations: 1 country
• Sites: 13

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.

Conditions

Melanoma

Keywords

SLNE; SPECT/CT

Outcome Measures

Primary Outcomes (1)

• Distant free metastasis survival (DFMS)

  The number of patients free of distant metastasis after randomization in arm A compared to DFMS in arm B.

  6 years

Secondary Outcomes (10)

• Overall survival (OS)

  6 years

• Disease-free survival (DFS)

  6 years

• False negative rate of SLN

  3 years

• Sensitivity

  3 years

• Complication rate

  6 years

Study Arms (2)

SPEC/CT

EXPERIMENTAL

SLNE with preoperative hybrid SPECT/CT

Procedure: SLNE with preoperative hybrid SPECT/CT

Standard

ACTIVE COMPARATOR

Standard SLNE (with planar preoperative lymphoscintigraphy)

Procedure: Standard SLNE

Interventions

SLNE with preoperative hybrid SPECT/CT PROCEDURE

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.

SPEC/CT

Standard SLNE PROCEDURE

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.

Standard

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Essen: lead

Study Sites (13)

Department of Dermatology, University Hospital Essen

Essen, North Rhine-Westphalia, 45122, Germany

Location

Hospital Augsburg, Department of Dermatology

Augsburg, 86156, Germany

Location

Vivantes Hospital Berlin Neukölln

Berlin, 12351, Germany

Location

University Hospital Bonn

Bonn, 53127, Germany

Location

Hospital Dresden Friedrichstadt, Department of Dermatology and Allergology

Dresden, 01067, Germany

Location

Universitätsklinik Dresden

Dresden, Germany

Location

Universitätskliniken Düsseldorf

Düsseldorf, Germany

Location

Universitätsklinikum Giessen

Giessen, 35392, Germany

Location

University Hospital Göttingen, Department of Dermatology

Göttingen, 37075, Germany

Location

Universitätsklinikum Hamburg Eppendorf

Hamburg, Germany

Location

University Hospital Heidelberg, Department of Dermatology

Heidelberg, 69120, Germany

Location

University Hospital Lübeck, Department of Dermatology

Lübeck, 23538, Germany

Location

University Hospital Tübingen

Tübingen, 72076, Germany

Location

Related Publications (1)

• Stoffels I, Herrmann K, Rekowski J, Jansen P, Schadendorf D, Stang A, Klode J. Sentinel lymph node excision with or without preoperative hybrid single-photon emission computed tomography/computed tomography (SPECT/CT) in melanoma: study protocol for a multicentric randomized controlled trial. Trials. 2019 Feb 4;20(1):99. doi: 10.1186/s13063-019-3197-7.

  PMID: 30717811 DERIVED

MeSH Terms

Conditions

Melanoma

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Ingo Stoffels, MD

  Department of Dermatology, University Hospital Essen

  PRINCIPAL INVESTIGATOR

• Joachim Klode, MD

  Department of Dermatology, University Hospital Essen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr. med

Study Record Dates

• First Submitted: September 20, 2018
• First Posted: September 25, 2018
• Study Start: September 25, 2018
• Primary Completion: June 1, 2025
• Study Completion: June 1, 2025
• Last Updated: May 10, 2023

Record last verified: 2023-05

Locations

DE (13)