Phase I clinical trial using a novel CCK-2/gastrin receptor-localizing radiolabelled peptide probe for personalized diagnosis and therapy of patients with progressive or metastatic medullary thyroid carcinoma - GRAN-T-MTC

Azienda Ospedaliero-Universitaria Pisana0 个研究点目标入组 5 人开始时间: 待定最近更新: 2024年4月23日

适应症

试验速览

暂无简介。

•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.
•3. Doubling time (DT) of serum calcitonin level within two years prior to study entry and no evidence of disease.
•4. Karnofsky performance status >50%.
•5. Life expectancy of more than 6 months.
•6. Male or female patients aged >18 years without upper age limit.

•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.
•6. Treatment with Tyrosine kinase inhibitors
•Related to the patient:
•7. Pregnancy, breast-feeding.
•8. Known hypersensitivity to gastrin analogues.
•9. Patients with concurrent illnesses that might preclude study
•completion or interfere with study results.
•10. Patients with bladder outflow obstruction or unmanageable urinary
•incontinence.
•11. Clinical diagnosis of disseminated intravascular coagulation.
•12. Serum creatinine >170 *mol/L, GFR < 40 mL/min
•13. Known history of hypersensitivity to Gelofusine or any other contraindications to Gelofusine infusion

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