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

Primary Purpose

Melanoma

Status

Active

Phase

Not Applicable

Locations

Germany

Study Type

Interventional

Intervention

SLNE with preoperative hybrid SPECT/CT

Standard SLNE

About this trial

This is an interventional treatment trial for Melanoma focused on measuring SLNE, SPECT/CT

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Department of Dermatology, University Hospital Essen
Hospital Augsburg, Department of Dermatology
Vivantes Hospital Berlin Neukölln
University Hospital Bonn
Hospital Dresden Friedrichstadt, Department of Dermatology and Allergology
Universitätsklinik Dresden
Universitätskliniken Düsseldorf
Universitätsklinikum Giessen
University Hospital Göttingen, Department of Dermatology
Universitätsklinikum Hamburg Eppendorf
University Hospital Heidelberg, Department of Dermatology
University Hospital Lübeck, Department of Dermatology
University Hospital Tübingen

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

SPEC/CT

Standard

Arm Description

SLNE with preoperative hybrid SPECT/CT

Standard SLNE (with planar preoperative lymphoscintigraphy)

Outcomes

Primary Outcome Measures

Distant free metastasis survival (DFMS)

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

Secondary Outcome Measures

Overall survival (OS)

Overall Survival (OS) of a patient defined as the time frame start of run-in phase until documented date of death

Disease-free survival (DFS)

The number of patients alive and free of disease after randomization in arm A compared to DFS in arm B.

False negative rate of SLN

Rate of local relapse within a 12 month follow-up period (false negative rate of sentinel lymph nodes [SLN])

Sensitivity

Number of positive SLN

Complication rate

Intraoperative and postoperative complications due to SLNE

Quality of Life (QoL)

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.

Quality adjusted life years (QALY)

Assessing the health economic relevance

Number of inpatient days

To calculate the cost of the two treatment options the number of inpatient days will be counted and compared for each treatment arm.

Overall costs during hospital stays

Overall costs during hospital stays will be summed up and compared.

Incidence of Treatment-Emergent Adverse Events

Intervention-related safety events will be documented during the trial period

Full Information

NCT ID

NCT03683550

First Posted

September 20, 2018

Last Updated

May 9, 2023

Sponsor

University Hospital, Essen

1. Study Identification

Unique Protocol Identification Number

NCT03683550

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

September 25, 2018 (Actual)

Primary Completion Date

June 2025 (Anticipated)

Study Completion Date

June 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University Hospital, Essen

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Melanoma

Keywords

SLNE, SPECT/CT

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

836 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

SPEC/CT

Arm Type

Experimental

Arm Description

SLNE with preoperative hybrid SPECT/CT

Arm Title

Standard

Arm Type

Active Comparator

Arm Description

Standard SLNE (with planar preoperative lymphoscintigraphy)

Intervention Type

Procedure

Intervention Name(s)

SLNE with preoperative hybrid SPECT/CT

Intervention Description

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.

Intervention Type

Procedure

Intervention Name(s)

Standard SLNE

Intervention Description

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 Measure Information:

Title

Distant free metastasis survival (DFMS)

Description

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

Time Frame

6 years

Secondary Outcome Measure Information:

Title

Overall survival (OS)

Description

Overall Survival (OS) of a patient defined as the time frame start of run-in phase until documented date of death

Time Frame

6 years

Title

Disease-free survival (DFS)

Description

The number of patients alive and free of disease after randomization in arm A compared to DFS in arm B.

Time Frame

6 years

Title

False negative rate of SLN

Description

Rate of local relapse within a 12 month follow-up period (false negative rate of sentinel lymph nodes [SLN])

Time Frame

3 years

Title

Sensitivity

Description

Number of positive SLN

Time Frame

3 years

Title

Complication rate

Description

Intraoperative and postoperative complications due to SLNE

Time Frame

6 years

Title

Quality of Life (QoL)

Description

Time Frame

6 years

Title

Quality adjusted life years (QALY)

Description

Assessing the health economic relevance

Time Frame

6 years

Title

Number of inpatient days

Description

To calculate the cost of the two treatment options the number of inpatient days will be counted and compared for each treatment arm.

Time Frame

6 years

Title

Overall costs during hospital stays

Description

Overall costs during hospital stays will be summed up and compared.

Time Frame

6 years

Title

Incidence of Treatment-Emergent Adverse Events

Description

Intervention-related safety events will be documented during the trial period

Time Frame

6 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ingo Stoffels, MD

Organizational Affiliation

Department of Dermatology, University Hospital Essen

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Joachim Klode, MD

Organizational Affiliation

Department of Dermatology, University Hospital Essen

Official's Role

Principal Investigator

Facility Information:

Facility Name

Department of Dermatology, University Hospital Essen

City

Essen

State/Province

NRW

ZIP/Postal Code

45122

Country

Germany

Facility Name

Hospital Augsburg, Department of Dermatology

City

Augsburg

ZIP/Postal Code

86156

Country

Germany

Facility Name

Vivantes Hospital Berlin Neukölln

City

Berlin

ZIP/Postal Code

12351

Country

Germany

Facility Name

University Hospital Bonn

City

Bonn

ZIP/Postal Code

53127

Country

Germany

Facility Name

Hospital Dresden Friedrichstadt, Department of Dermatology and Allergology

City

Dresden

ZIP/Postal Code

01067

Country

Germany

Facility Name

Universitätsklinik Dresden

City

Dresden

Country

Germany

Facility Name

Universitätskliniken Düsseldorf

City

Düsseldorf

Country

Germany

Facility Name

Universitätsklinikum Giessen

City

Giessen

ZIP/Postal Code

35392

Country

Germany

Facility Name

University Hospital Göttingen, Department of Dermatology

City

Göttingen

ZIP/Postal Code

37075

Country

Germany

Facility Name

Universitätsklinikum Hamburg Eppendorf

City

Hamburg

Country

Germany

Facility Name

University Hospital Heidelberg, Department of Dermatology

City

Heidelberg

ZIP/Postal Code

69120

Country

Germany

Facility Name

University Hospital Lübeck, Department of Dermatology

City

Lübeck

ZIP/Postal Code

23538

Country

Germany

Facility Name

University Hospital Tübingen

City

Tübingen

ZIP/Postal Code

72076

Country

Germany

12. IPD Sharing Statement

Citations:

PubMed Identifier

30717811

Citation

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.

Results Reference

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

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