EUCTR2018-004389-33-FI
Active, Not Recruiting
Phase 1
Contrast enhanced ultrasound a novel technique in lymphatic imaging – A Prospective study
Olli Lahtinen0 sites160 target enrollmentMay 20, 2020
ConditionsMedDRA version: 20.0Level: LLTClassification code 10025233Term: LymphedemaSystem Organ Class: 100000004866MedDRA version: 20.0Level: LLTClassification code 10054561Term: Post-mastectomy lymphedema syndromeSystem Organ Class: 100000004863MedDRA version: 20.0Level: LLTClassification code 10036389Term: Postmastectomy lymphedema syndromeSystem Organ Class: 100000004863Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01]
DrugsSonazoid
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- MedDRA version: 20.0Level: LLTClassification code 10025233Term: LymphedemaSystem Organ Class: 100000004866
- Sponsor
- Olli Lahtinen
- Enrollment
- 160
- Status
- Active, Not Recruiting
- Last Updated
- 5 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1st branch: 50 healthy volunteers with no prior upper arm surgery
- •2nd branch: 50 consecutive patients with known history of breast cancer or upper arm melanoma with possible known lymphedema.
- •3rd branch: 30 patients with prior history of breast cancer and possible lymphedema. All consecutive breast cancer patients having traditional lymphoscintigraphy as a part of their standard imaging are also recruited for this branch.
- •4th branch: 30 consecutive patients with newly diagnosed vulvar cancer to whom sentinel biopsy will be scheduled.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1\.2 Adults (18\-64 years) yes
- •F.1\.2\.1 Number of subjects for this age range 100
- •F.1\.3 Elderly (\>\=65 years) yes
- •F.1\.3\.1 Number of subjects for this age range 60
Exclusion Criteria
- •1\) Vulvar carcinoma patients who won’t have traditional lymphoscintigraphy (branch 4\) 2\) Vulvar carcinoma patients with prior lymphadenectomy in the groin area (branch 4\) 3\) People with egg allergy (all branches) 4\) Patients to whom gadolinium contrast agent is contraindicated (branch 3\) 5\) Patients who have claustrophobia and can’t enter the MRI (branch 3\). 6\) Patients who have foreign material in their body which is contraindicated for MRI
Outcomes
Primary Outcomes
Not specified
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