medullary thyroid cancer medullary thyroid carcinoma
Conditions
Interventions
The research will undergo a scan with IN111-CP04 and possibly an administration
of Gelofusine if by lottery assigned
Sponsors
Azienda Ospedaliero-Universitaria Pisana
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome measures 1. Safety of intravenous administration of CP04 at low-dose (diagnostic amount) and high-dose (therapeutic amount) peptide radiolabelled with 200±10% MBq of 111In (diagnostic amount) will be assessed by type, frequency, severity, timing and relation to the studied radiopharmaceutical administration of adverse events and laboratory abnormalities based on Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 2. Biodistribution and pharmacokinetics\for target lesion and for discernible organs will be evaluated from sequential planar images. Calculation of the residence time of 111In in discernible thoracic and abdominal organs, target lesion and blood will be performed and organ as well as tumour doses (mGy/MBq) calculated. These data will provide all required data for evaluation of the feasibility of a therapeutic application of CP04. 3. Diagnostic sensitivity/specificity of 111In CP04 to detect cancer lesions for both diagnostic and therapeutic peptide amount by Qualitative Visual Analysis (number of patients with uptake at site of lesion, the number of lesions with abnormal tracer uptake at scintigraphy, the number and site of lesions with pathological uptake detected per verifiable organ or body region relative to those detected by conventional imaging) 4. Influence of a diagnostic amount of CP04 peptide vs. a therapeutic amount of peptide on tumour and organ uptake, the identification of the time points post-injection with the highest observed number of lesions and the highest tumour/background ratios will be performed. 5. The relative decrease of kidney adsorbed dose after co-administration of Gelofusine. | — |
Countries
Netherlands
Outcome results
None listed