A novel method to improve the detection of cancer and metastases by peptide scanning under the protection of enzyme inhibitors: PepProtect 1

Conditions: medullary cancer of the thyroid
medullary carcinoma of the thyroid
10014713

Registration Number: NL-OMON44441

Lead Sponsor: Erasmus MC, Universitair Medisch Centrum Rotterdam

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: 12

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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>1. To monitor the safety and tolerability of racecadotril in combination with<br /><br>111In-DOTA-MG11; adverse events will be monitored according to international<br /><br>standards, CTCAE 4.03<br /><br>2. To study in patients whether the neutral endopeptidase (NEP) inhibitor<br /><br>racecadotril improves the in vivo stability of the radiopeptide<br /><br>111In-DOTA-MG11; percentage intact radiopeptide, 10 min. after injection, will<br /><br>be measured</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>1. To study whether the tumour uptake of 111In-DOTA-MG11 is<br /><br>improved in parallel with the improved in vivo stability of 111In-DOTAMG11<br /><br>by racecadotril protection.<br /><br>2. To explore the sensitivity of [racecadotril-protected] 111In-DOTAMG11<br /><br>scintigraphy (planar and SPECT/CT) to detect medullary thyroid<br /><br>cancer lesions</p><br>