NL-OMON44441
Not Yet Recruiting
N/A
A novel method to improve the detection of cancer and metastases by peptide scanning under the protection of enzyme inhibitors: PepProtect 1 - PepProtect 1
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Erasmus MC, Universitair Medisch Centrum Rotterdam
- Enrollment
- 12
- Status
- Not Yet Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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
- •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 \<60 mL/min/1\.73 m2\)
- •4\. Impaired liver function (cirrhosis, grade B of the Child\-Pugh classification; or hepatic enzyme levels \>3x upper limit of normal)
- •5\. Known allergy or hypersensitivity to gastrin analogues or any of the components of the study medications.
- •6\. Any use of NEP\-inhibitors within 30 days prior to the study; any use of experimental medication or other medication that potentially interfere with racecadotril or In111\-DOTA\-MG11\.
- •7\. Any use of ACE inhibitors within 3 days of racecadotril administrations.
Outcomes
Primary Outcomes
Not specified
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