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:
2025-12-25 @ 3:19 AM
Ignite Modification Date:
2025-12-25 @ 3:19 AM
NCT ID:
NCT04847505
Eligibility Criteria:
Inclusion Criteria:
1. Clinical requisition for a 68Ga-DOTA-TATE PET/CT signed by a referring doctor
2. Patients with suspected or proven tumors expressing somatostatin receptors
3. Informed consent by patient (or parents if patient is less than 18 years of age)
Exclusion Criteria:
1. \*Pregnancy (not an absolute exclusion). See below\*.
2. Patient refusal to participate.
3. Prior severe anaphylactic reaction to DOTA-TATE or somatostatin analogs.
* In the case of a diagnostic procedure in a patient who is or may be pregnant, the principle of benefits-disadvantages would be applied following an in-depth discussion with the treating physicians and the patient. In this context, any clinical situation in which the patient's life would be at stake by excluding her from the study would be considered. The conditions to decide whether to include the patient would be:
* Severe medical condition involving the life of the pregnant woman and/or the fetus;
* Existing treatments that are ineffective or may present toxicity to the woman and/or fetus;
* High clinical suspicion of a somatostatin receptor overexpressing tumour;
* Negative, indeterminate or contraindicated first-line imaging tests;
* Therapeutic gesture considered during pregnancy based on the results of the examination, which may include termination of pregnancy or premature delivery;
* Documented discussion with the treating team and the patient;
* Patient agrees.
Healthy Volunteers:
False
Sex:
ALL
Study:
NCT04847505
Study Brief:
Protocol Section:
NCT04847505