medullary cancer of the thyroid medullary carcinoma of the thyroid
Conditions
Interventions
Patients will twice undergo a scan with 111-In-DOTA-MG11, once at baseline
without racecadotril and once with racecadotril, as intended intervention.
Sponsors
Erasmus MC, Universitair Medisch Centrum Rotterdam
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Related to the medullary cancer of the thyroid: 1. Histologically documented medullary cancer of the thyroid (MTC), or with elevated tumour marker (serum calcitonin) after previous treatment(s) for MTC Related to the patient: 2. Life expectancy of more than 6 months. 3. WHO performance status 0 or 1 4. Male or female patients aged >18 years without upper age limit.
Exclusion criteria
Exclusion criteria: 1. Patients requiring treatment of the tumour urgently, before assessments required for the study can be completed. 2. Pregnancy or breast feeding. Negative pregnancy test is required in female patients with child-bearing potential. 3. Impaired renal function (eGFR
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. To monitor the safety and tolerability of racecadotril in combination with 111In-DOTA-MG11; adverse events will be monitored according to international standards, CTCAE 4.03 2. To study in patients whether the neutral endopeptidase (NEP) inhibitor racecadotril improves the in vivo stability of the radiopeptide 111In-DOTA-MG11; percentage intact radiopeptide, 10 min. after injection, will be measured | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. To study whether the tumour uptake of 111In-DOTA-MG11 is improved in parallel with the improved in vivo stability of 111In-DOTAMG11 by racecadotril protection. 2. To explore the sensitivity of [racecadotril-protected] 111In-DOTAMG11 scintigraphy (planar and SPECT/CT) to detect medullary thyroid cancer lesions | — |
Countries
Netherlands
Outcome results
None listed