Skip to main content
MedPathMedPath Home
Clinical Trials/EUCTR2012-002244-25-GB
EUCTR2012-002244-25-GB
Active, not recruiting
Phase 1

Prospective feasibility study for the evaluation of indocyanine green and near-infrared imaging in sentinel lymph node biopsy for cutaneous melanoma patients: The RED-GREEN-BLUE melanoma study. - Feasibility of indocyanine green in sentinel node biopsy in melanoma

orfolk & Norwich University Hospital0 sites60 target enrollmentJune 12, 2012
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit
ConditionsCutaneous MelanomaMedDRA version: 20.0 Level: LLT Classification code 10025655 Term: Malignant melanoma of skin System Organ Class: 100000004864MedDRA version: 20.0 Level: LLT Classification code 10068478 Term: Sentinel lymphadenectomy System Organ Class: 100000004865Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Surgical Procedures, Operative [E04]
DrugsICG-PULSION

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Cutaneous Melanoma
Sponsor
orfolk & Norwich University Hospital
Enrollment
60
Status
Active, not recruiting
Last Updated
7 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
June 12, 2012
End Date
TBD
Last Updated
7 years ago
Study Type
Interventional clinical trial of medicinal product

Investigators

Sponsor
orfolk & Norwich University Hospital

Eligibility Criteria

Inclusion Criteria

  • •Any patients eligible for Sentinel lymph node biopsy for cutaneous melanoma
  • •Are the trial subjects under 18? no
  • •Number of subjects for this age range: 0
  • •F.1\.2 Adults (18\-64 years) yes
  • •F.1\.2\.1 Number of subjects for this age range 35
  • •F.1\.3 Elderly (\>\=65 years) yes
  • •F.1\.3\.1 Number of subjects for this age range 25

Exclusion Criteria

  • •1\. Patients unable to give informed consent.
  • •2\. Patients with reduced mental capacity to give informed consent.
  • •3\. Vulnerable adults, children, prisoners.
  • •4\. Patients who already have undergone lymph node dissection in a potentially draining lymph node field.
  • •5\. Patients where the preoperative lymphoscintigraphy has failed.
  • •6\. Patients who are allergic to indocyanine green
  • •7\. Pregnant or lactating women
  • •8\. Patients with hyperthyroidism or with toxic thyroid adenomas
  • •9\. Palpable lymph nodes in draining regional nodal field

Outcomes

Primary Outcomes

Not specified

Similar Trials

Recruiting
Phase 1
A prospective study to evaluate the feasibility and usefulness of a smartphone site aimed at improving taste disorders and nutritional status in cancer patients undergoing chemotherapy
JPRN-UMIN000046647ational Cancer Center Hospital,230
Recruiting
Not Applicable
A prospective study evaluating the feasibility and safety of EUS-guided biliary drainage using a modified repositionable plastic stentCases requiring biliary drainage due to biliary disease (including benign and malignant disease)
JPRN-UMIN000048423Tokyo Medical University100
Completed
Not Applicable
Evaluation of stimulation on overactive bladder patientsOveractive bladderRenal and Urogenital - Other renal and urogenital disorders
ACTRN12618001582246Five Corners Pty Ltd3
Recruiting
Phase 2
Stereotactic body radiation therapy in lymph nodal oligometastatic diseaseHealth Condition 1: C00-D49- Neoplasms
CTRI/2023/02/049773PGIMER CHANDIGARH
Active, not recruiting
Phase 3
A prospective study in adult patients with pituitary adenoma treated with radiotherapy excluding the hippocampalHealth Condition 1: G938- Other specified disorders of brainHealth Condition 2: null- Patients above 18 years of age diagnosed with pituitary adenomas.
CTRI/2018/11/016345Tata Memorial Hospital