Within-patient comparison of Senti-Scint and ICG-99mTc-nanocolloid for sentinel node biopsy of melanoma of the head and neck, of the trunk or of an extremity

Within-patient comparison of Senti-Scint and ICG-99mTc-nanocolloid for sentinel node biopsy of melanoma of the head and neck, of the trunk or of an extremity - 99mTc-Senti-Scintvs. ICG-99mTc-nanocolloid

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON40198

Enrollment

Registered

2014-04-24

Start date

2014-10-06

Completion date

Unknown

Last updated

2024-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

cutaneous melanoma Melanoma

Interventions

The study will be performed in a two-day protocol. Day 1: The four sites for the radiocolloid injection deposits will be marked with an indelible marker pen. Thereafter, 99mTc-Senti-Scint will be a

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - Patients > 18 years;- Patients with a primary melanoma of the head and neck (including skull);- Patients with a primary melanoma on the trunk;- Patients with a primary melanoma of an extremity;- Patients have a clinically node negative (cN0) regional lymph node status;- Patients are scheduled for (re-)excision of the melanoma (scar) and a subsequent sentinel node biopsy procedure

Exclusion criteria

Exclusion criteria: - Patients with a known allergy to patent blue;- Patients who are pregnant or nursing mothers;- Patients with a history of hypersensitivity reactions to products containing human serum albumin;- Patients with a history of an iodine allergy;- Patients with a hyperthyroid or thyroidal adenoma;- Patients with known kidney insufficiency

Design outcomes

Primary

Measure	Time frame
1) Number of higher-echelon nodes following lymphoscintigraphy and SPECT/CT imaging with either approach.	—

Secondary

Measure	Time frame
1) Number of draining basins and sentinel nodes visualized with lymphoscintigraphy and SPECT/CT following 99mTc-Senti-Scint administration and after ICG-99mTc-nanocolloid administration.	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)