Radiolabelled CCK-2/Gastrin Receptor Analogue for Personalized Theranostic Strategy in Advanced MTC

Launched by PAOLA ANNA ERBA · Aug 8, 2017

Keywords

ClinConnect Summary

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 outcome on new biomarkers, conjugate CP04 was chosen on the basis of its good stability and affinity to CCK-2/gastrin receptor in vitro, as well as its favourable biodistribution and pharmacodynamic properties in vivo, preclinically. Within this project the tracer may get a chance to be introduced to clinical practice as a more selective and efficient tool for the diagnosis, early detection and thera...

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• Related to the medullary cancer of the thyroid:
• • 1. Histologically documented medullary cancer of the thyroid.
• • 2. Presence of more than one distant or nodal, surgically untreatable metastases confirmed with either 18F-FDG PET/CT or enhanced-CT or MRI OR
• • 3. Doubling time (DT) of serum calcitonin level less than two years prior to study entry and negative imaging.
• • 4. Karnofsky performance status \> 50%.
• • 5. Life expectancy of more than 6 months.
• Related to the patient:
• • 6. Male or female patients aged \>18 years without upper age limit.
• • 7. Ability to understand and willingness to sign a written informed consent document.
• • 8. Written informed consent obtained according to international guidelines and local laws.
• Exclusion Criteria:
• Related to the MTC:
• • 1. Patients with surgically treatable medullary thyroid cancer.
• • 2. Patients with history of second malignancy other than basal cell carcinoma of the skin.
• Related to previous or concomitant therapies :
• • 3. Participation in any other investigational trial within 3 months of study entry.
• • 4. Previous external beam radiation therapy within two years.
• • 5. Organ allograft requiring immunosuppressive therapy.
• Related to the patient:
• • 6. Pregnancy, breast-feeding.
• • 7. Known hypersensitivity to gastrin analogues.
• • 8. Patients with concurrent illnesses that might preclude study completion or interfere with study results.
• • 9. Patients with bladder outflow obstruction or unmanageable urinary incontinence.
• • 10. Clinical diagnosis of disseminated intravascular coagulation.
• • 11. Serum creatinine \>170 μmol/L, GFR \< 40 mL/min
• • 12. Known history of hypersensitivity to gelofusine /gelaspan or any other contraindications to gelofusine/gelaspan infusion

Trial Officials