Metastatic Thyroid Cancer Therapy Optimization With 124I PET Dosimetry

• Status: Recruiting
• Trial end date: 2024-09-30
• Target enrollment: 0
• Participant gender: All

Summary

Failure of conventional radioiodine therapy of metastatic differentiated thyroid cancer could be explained by:

• a suboptimal therapeutic approach, based on the administration of empirically fixed amount of radioactivity

• the presence of lesions with impaired iodine uptake, due to the expression of specific mutations

The study aims to:

• optimize therapy with pre-treatment 124-I blood and lesion dosimetry

• collect genetic data to check if specific mutations and/or miRNA over-expression could be related to low iodine uptake or to radioresistance

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Carlo Chiesa
• Collaborator: Associazione Italiana per la Ricerca sul Cancro

Criteria

Inclusion Criteria:

• Histo-pathological diagnosis of DTC

• At least one documented non surgically-curable soft-tissue metastasis previously untreated

• ECOG performance status = 0 - 1

• Life expectancy > 6 months

• Females of childbearing age must have negative serum pregnancy test prior to registration and agree to use birth control throughout the study and for 6 months after completion of therapy

• Preserved hematologic and renal function (hemoglobin > 10 g/dL; WBC > 3500/uL; neutrophils > 50%; PLT > 100000/uL; albumin ≥ 2.5 g/dL; creatinine ≤ 2 mg/dL)

• Signed informed consent

Exclusion Criteria:

• All lesions surgically resectable

• Minimal lymph nodal disease (diameter < 1 cm, up to 2 nodes)

• Patient with skeletal metastases only

• Lung diffuse miliary micro-metastases

• Ongoing pregnancy

• Breast-feeding (enrollment could be considered after suspension)

• Refusal of male and female patients to use an effective contraception method during the study and for 6 months after completion of protocol therapy

• Impossibility to undergo follow-up procedures

• Presence of medical, psychiatric or surgical condition, not adequately controlled by treatment, which would likely affect subjects' ability to complete the protocol

• Assumption of any anti-tumor therapy including chemotherapy, biological or investigational drug treatments

• Assumption of any myelotoxic drugs

• Previous or concomitant assumption of Amiodarone

• Any other oncologic disease that required treatment in the last 5 years.

• Participation in a clinical trial in which an investigational drug was administered within 30 days or 5 half-lives prior to the study drug.