E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated | |
E.1.1.1 | Medical condition in easily understood language |
Study design evaluates lymphatic vessels in both healthy volunteers and patients with prior history of malignant diseases resulting in lymphedema. |
|
E.1.1.2 | Therapeutic area | Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10025233 |
E.1.2 | Term | Lymphedema |
E.1.2 | System Organ Class | 100000004866 |
|
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10054561 |
E.1.2 | Term | Post-mastectomy lymphedema syndrome |
E.1.2 | System Organ Class | 100000004863 |
|
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10036389 |
E.1.2 | Term | Postmastectomy lymphedema syndrome |
E.1.2 | System Organ Class | 100000004863 |
|
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To evaluate the feasibility of the contrast enhanced ultrasound (CEUS) imaging in lymphatic vessels and to evaluate the rate of finding lymphedema and compare CEUS with other imaging modalities. |
|
E.2.2 | Secondary objectives of the trial |
|
E.2.3 | Trial contains a sub-study | No |
E.2.3.1 | Full title, date and version of each sub-study and their related objectives |
|
E.3 | Principal 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. |
|
E.4 | Principal 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 |
|
E.5 End points |
E.5.1 | Primary end point(s) | |
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | Yes |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | No |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
The study takes place when the patients have their normal scheduled appointments with their physicians and lasts only the one visit to the radiology department on behalf of the patients. |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 10 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |