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

Completed

• Conditions: medullary thyroid cancer; medullary thyroid carcinoma; 10014713

• Registration Number: NL-OMON46298
• Lead Sponsor: Azienda Ospedaliero-Universitaria Pisana

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 5

Inclusion Criteria

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.

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.
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

Study & Design

• Study Type: Interventional
• Study Design: Not specified