Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 2:55 PM
Ignite Modification Date:
2025-12-24 @ 2:55 PM
NCT ID:
NCT03246659
Eligibility Criteria:
Inclusion Criteria:
Related to the medullary cancer of the thyroid:
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 OR
3. Doubling time (DT) of serum calcitonin level less than two years prior to study entry and negative imaging.
4. Karnofsky performance status \> 50%.
5. Life expectancy of more than 6 months.
Related to the patient:
6. Male or female patients aged \>18 years without upper age limit.
7. Ability to understand and willingness to sign a written informed consent document.
8. Written informed consent obtained according to international guidelines and local laws.
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.
Related to the patient:
6. Pregnancy, breast-feeding.
7. Known hypersensitivity to gastrin analogues.
8. Patients with concurrent illnesses that might preclude study completion or interfere with study results.
9. Patients with bladder outflow obstruction or unmanageable urinary incontinence.
10. Clinical diagnosis of disseminated intravascular coagulation.
11. Serum creatinine \>170 μmol/L, GFR \< 40 mL/min
12. Known history of hypersensitivity to gelofusine /gelaspan or any other contraindications to gelofusine/gelaspan infusion
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03246659
Study Brief:
Protocol Section:
NCT03246659