AzTrials
AzTrials

MelanomaNCT03683550

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

A study testing SLNE with preoperative hybrid SPECT/CT and Standard SLNE in people with Melanoma, run by University Hospital, Essen at 13 sites in Germany.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Melanoma
What is being tested?
SLNE with preoperative hybrid SPECT/CT and Standard SLNE
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
836 participants
Where
13 sitesGermany
Study dates
25 Sep 2018to Jun 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)
Show all 10Show fewer
  • 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

Who cannot join

  • 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
Show all 13Show fewer
  • 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

Trial locations and contacts

13 sites in 1 country.

13 sites in 1 country

Germany13 sites

  • Hospital Augsburg, Department of Dermatology

    Augsburg, 86156

  • Vivantes Hospital Berlin Neukölln

    Berlin, 12351

  • University Hospital Bonn

    Bonn, 53127

  • Hospital Dresden Friedrichstadt, Department of Dermatology and Allergology

    Dresden, 01067

  • Universitätsklinik Dresden

    Dresden

  • Universitätskliniken Düsseldorf

    Düsseldorf

  • Department of Dermatology, University Hospital Essen

    Essen, North Rhine-Westphalia, 45122

  • Universitätsklinikum Giessen

    Giessen, 35392

  • University Hospital Göttingen, Department of Dermatology

    Göttingen, 37075

  • Universitätsklinikum Hamburg Eppendorf

    Hamburg

  • University Hospital Heidelberg, Department of Dermatology

    Heidelberg, 69120

  • University Hospital Lübeck, Department of Dermatology

    Lübeck, 23538

  • University Hospital Tübingen

    Tübingen, 72076

Other trials in Germany

About this study

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

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.

Read the 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.

Conditions
Melanoma
Being tested
SLNE with preoperative hybrid SPECT/CT, Standard SLNE
Keywords
SLNE, SPECT/CT
Medical subject headings
Melanoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SLNE with preoperative hybrid SPECT/CTProcedure or surgery

    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.

  • Standard SLNEProcedure or surgery

    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.

Study groups in NCT03683550
Study groupRoleWhat they receive
SPEC/CTExperimentalSLNE with preoperative hybrid SPECT/CT
Receives: Procedure: SLNE with preoperative hybrid SPECT/CT
StandardActive comparatorStandard SLNE (with planar preoperative lymphoscintigraphy)
Receives: Procedure: Standard SLNE

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 6 years

Secondary outcomes (10)

  1. Overall survival (OS)

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

    Measured: 6 years

  2. Disease-free survival (DFS)

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

    Measured: 6 years

  3. False negative rate of SLN

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

    Measured: 3 years

  4. Sensitivity

    Number of positive SLN

    Measured: 3 years

  5. Complication rate

    Intraoperative and postoperative complications due to SLNE

    Measured: 6 years

  6. 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.

    Measured: 6 years

  7. Quality adjusted life years (QALY)

    Assessing the health economic relevance

    Measured: 6 years

  8. 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.

    Measured: 6 years

  9. Overall costs during hospital stays

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

    Measured: 6 years

  10. Incidence of Treatment-Emergent Adverse Events

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

    Measured: 6 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Sep 2018
  2. Study start25 Sep 2018
  3. Primary completionJun 2025 (estimated)
  4. Study completionJun 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
836 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03683550
Sponsor's protocol ID
SNEPS 2018
Status last verified
May 2023
First submitted
20 Sep 2018
Last updated
10 May 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 30717811

Questions about this trial

What is this clinical trial studying?

A study testing SLNE with preoperative hybrid SPECT/CT and Standard SLNE in people with Melanoma, run by University Hospital, Essen at 13 sites in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 10 May 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 13 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Distant free metastasis survival (DFMS) (time frame: 6 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03683550, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 May 2023.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in