NCT05467137

Brief Summary

In this study the investigators try to identify the sentinel lymph node in patients with stage Ib-III melanoma in a non-invasive manner without the use of a radioactive tracer by using the new MSOT technology.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
10

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Sep 2022

Shorter than P25 for phase_4

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 1, 2022

Completed
19 days until next milestone

First Posted

Study publicly available on registry

July 20, 2022

Completed
1 month until next milestone

Study Start

First participant enrolled

September 1, 2022

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2022

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2023

Completed
Last Updated

July 20, 2022

Status Verified

July 1, 2022

Enrollment Period

2 months

First QC Date

July 1, 2022

Last Update Submit

July 15, 2022

Conditions

Melanoma, Stage IMelanoma, Stage IIMelanoma Stage III

Outcome Measures

Primary Outcomes (1)

  • Concordance rate of SLNs identified by MSOT imaging and ICG versus the standard of care with 99mTc-nanocolloid Tc99m and lymphoscintigraphic imaging

    Through study completion (an average of 1 year)

Secondary Outcomes (1)

  • Patient characteristics

    Through study completion (an average of 1 year)

Study Arms (1)

Standard of care + MSOT

EXPERIMENTAL

Standard of care + MSOT

Device: MSOT

Interventions

MSOTDEVICE

MSOT imaging (after ICG injection)

Standard of care + MSOT

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with grade Ib- III melanoma scheduled for SLNB and/or surgical excision.
  • Patients must be \> 18 years old and be able to give informed consent.
  • Skintype I-IV following Fitzpatrick skin classification (MSOT less reliable in skin types \>IV)

You may not qualify if:

  • Apparent hyperthyroidism or autonomous thyroid adenoma of the thyroid gland
  • Prior surgery or radiotherapy on involved lymph nodes / area
  • Major surgery within 28 days before tracer administration
  • History of iodine allergy or anaphylactic reactions to insect bites
  • Hypersensitivity to ICG or poorly tolerated ICG in the past
  • Unexplained allergic reaction in the past
  • Skin type \>IV following Fitzpatrick skin classification (MSOT less reliable)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Melanoma

Condition Hierarchy (Ancestors)

Neuroendocrine TumorsNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Nerve TissueNevi and MelanomasSkin NeoplasmsNeoplasms by SiteSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • van Leeuwen

    University Medical Center Groningen

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jutten

CONTACT

0031 50 361 6161e.jutten@umcg.nl

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 1, 2022

First Posted

July 20, 2022

Study Start

September 1, 2022

Primary Completion

November 1, 2022

Study Completion

March 1, 2023

Last Updated

July 20, 2022

Record last verified: 2022-07