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Personalized therapy of metastatic thyroid cancer: biological characterization and optimization with 124I PET dosimetry
EU CTIS ID: 2024-516273-80-00
What this study is testing
-investigate if dosimetry-based 131I administration may increase efficacy as compared to that obtained with fixed activity, with an acceptable toxicity in DTC patients with soft tissue and skeletal metastasis: -study if the mutational status, the gene expression and the variations of miRNA profiles before and after therapy of DTCs may be related to lesions’ refractoriness, even to personalized, 131I therapy
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Histo-pathological diagnosis of DTC
- At least one documented non surgically-curable soft-tissue metastasis previously untreated
- ECOG performance status = 0 - 1
- Age ≥ 18 years old
- 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
You likely can't join if
- All lesions surgically resectable
- Assumption of any myelotoxic drugs
- Previous or concomitant assumption of Amiodarone
- Any other oncologic disease that required systemic treatment in the last 5 years. Cases who received previous loco-regional therapy on non-target lesions can be included (for example radiotherapy or surgery)
- Participation in a clinical trial in which an investigational drug was administered within 30 days or 5 half-lives prior to the study drug.
- Hypersensitivity: history of allergic reactions or hypersensitivity to the active substance, to any of the excipients, to any of the components of the radiolabelled radiopharmaceutical.
See the full eligibility criteria
- Histo-pathological diagnosis of DTC
- At least one documented non surgically-curable soft-tissue metastasis previously untreated
- ECOG performance status = 0 - 1
- Age ≥ 18 years old
- 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; neutrophilis > 50%; PLT > 100000/uL; albumin ≥ 2.5 g/dL; creatinine ≤ 2 mg/dL)
- Signed informed consent
- All lesions surgically resectable
- Assumption of any myelotoxic drugs
- Previous or concomitant assumption of Amiodarone
- Any other oncologic disease that required systemic treatment in the last 5 years. Cases who received previous loco-regional therapy on non-target lesions can be included (for example radiotherapy or surgery)
- Participation in a clinical trial in which an investigational drug was administered within 30 days or 5 half-lives prior to the study drug.
- Hypersensitivity: history of allergic reactions or hypersensitivity to the active substance, to any of the excipients, to any of the components of the radiolabelled radiopharmaceutical.
- Minimal lymph neck nodal disease (diameter < 1 cm, up to 2 nodes)
- Patient with skeletal metastases only
- Only lung uniformly diffuse miliary micro-metastases without other measurable nodules criteria
- Ongoing pregnancy (enrollment could be considered after delivery)
- 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
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.