Status:
COMPLETED
Radiolabelled CCK-2/Gastrin Receptor Analogue for Personalized Theranostic Strategy in Advanced MTC
Lead Sponsor:
Paola Anna Erba
Collaborating Sponsors:
Jagiellonian University
University Hospital Freiburg
Conditions:
Medullary Thyroid Carcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
The study is a phase I multicentre randomized, open, parallel-arm clinical trial conducted to investigate the IMP, namely 111In-CP04. The study consists of preclinical (to establish a clinically usef...
Detailed Description
The main goal of the study is to expand cancer preclinical research results on the usefulness of CCK-2/gastrin receptor in clinical practice. On the basis of last few years preclinical research outcom...
Eligibility Criteria
Inclusion
- Related to the medullary cancer of the thyroid:
- Histologically documented medullary cancer of the thyroid.
- Presence of more than one distant or nodal, surgically untreatable metastases confirmed with either 18F-FDG PET/CT or enhanced-CT or MRI OR
- Doubling time (DT) of serum calcitonin level less than two years prior to study entry and negative imaging.
- Karnofsky performance status \> 50%.
- Life expectancy of more than 6 months.
- Related to the patient:
- Male or female patients aged \>18 years without upper age limit.
- Ability to understand and willingness to sign a written informed consent document.
- Written informed consent obtained according to international guidelines and local laws.
Exclusion
- Related to the MTC:
- Patients with surgically treatable medullary thyroid cancer.
- Patients with history of second malignancy other than basal cell carcinoma of the skin.
- Related to previous or concomitant therapies :
- Participation in any other investigational trial within 3 months of study entry.
- Previous external beam radiation therapy within two years.
- Organ allograft requiring immunosuppressive therapy.
- Related to the patient:
- Pregnancy, breast-feeding.
- Known hypersensitivity to gastrin analogues.
- Patients with concurrent illnesses that might preclude study completion or interfere with study results.
- Patients with bladder outflow obstruction or unmanageable urinary incontinence.
- Clinical diagnosis of disseminated intravascular coagulation.
- Serum creatinine \>170 μmol/L, GFR \< 40 mL/min
- Known history of hypersensitivity to gelofusine /gelaspan or any other contraindications to gelofusine/gelaspan infusion
Key Trial Info
Start Date :
August 1 2016
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2018
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT03246659
Start Date
August 1 2016
End Date
November 1 2018
Last Update
March 20 2020
Active Locations (5)
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1
Department of Nuclear Medicine, Innsbruck Medical University
Innsbruck, Austria
2
Department of Nuclear Medicine, University Hospital Freiburg
Freiburg im Breisgau, Germany
3
Erasmus University Rotterdam
Rotterdam, Netherlands
4
Department of Endocrinology, Jagiellonian University Medical College
Krakow, Poland