Gamma Probe and Ultrasound Guided Fine Needle Aspiration Cytology of the Sentinel Node Trial

Gamma Probe and Ultrasound Guided Fine Needle Aspiration Cytology of the Sentinel Node Trial - GULF trial

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON41742

Enrollment

120

Registered

2015-04-13

Start date

2015-05-26

Completion date

Unknown

Last updated

2024-06-11

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

Conditions

melanoma & breast cancer lymph node metastasis

Interventions

All patients will undergo intervention in addition to standard care. The intervention consists of preoperative gamma probe and US guided detection of the SN to perform FNA. The first 10 patients add

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: New diagnosis of cT1b-4N0M0 melanoma or cT1-3N0M0 breast cancer, >/

Exclusion criteria

Exclusion criteria: - Clinically suspect lymph node - Other known malignancy with potential to disseminate to axillary or groin lymph nodes - Prior lymph node biopsy - No SN visible at lymphoscintigraphy

Design outcomes

Primary

Measure	Time frame
Feasibility of this intervention is evaluated by assessment of the sensitivity. A sensitivity of at least 90% is favoured.	—

Secondary

Measure	Time frame
1. A reproduction of reported identification rates (75-100%) is pursued. 2. Comparison of histological results of CNB versus SNB and versus FNA.	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)