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 @ 12:38 AM
Ignite Modification Date:
2025-12-25 @ 12:38 AM
NCT ID:
NCT04375267
Eligibility Criteria:
Inclusion Criteria:
* Histological or cytological diagnosis of neoplasia (not mandatory for meningioma)
* GEPNETs grade 3 or aggressive grade 2 tumours with a poor prognosis and a Ki67 \> 15% OR neuroendocrine tumours NOS after standard therapy OR thymomas/tumours of other origin after standard therapy OR meningiomas after standard therapy not suitable for surgery or radiotherapy
* Evidence of regional or distant metastases or localised disease not accessible for complete resection
* Measurable disease according to RECIST 1.1
* Evidence of somatostatin receptor positive disease detected by 68Ga-DOTA-TATE/TOC PET
* Progressive disease during the last 14 months based on CT or new lesions detected by 68Ga-DOTA-TATE PET.
* Performance status ECOG 0 - 1
* Life expectancy \> 6 months
* Age \>18 years, no upper age limit.
* Neutrophil count \>1,5 x 109/L
* Platelet count \>100 x 109/L
* Normal liver function regarding transaminases, PK and albumin. A raised bilirubin which can be considered an isolated effect of liver metastases is not a contraindication as long as the levels remain \<1.5 x ULN.
* GFR \> 50 ml/min
* Written informed consent from patients
* Evidence of post-menopausal status or negative urinary or serum pregnancy test for female pre-menopausal subjects. Women will be considered post-menopausal if they have been amenorrheic for 12 months without an alternative medical cause. The following age-specific requirements apply:
* Women \<50 years of age would be considered post-menopausal if they have been amenorrheic for 12 months or more following cessation of exogenous hormonal treatments and if they have luteinizing hormone and follicle-stimulating hormone levels in the post-menopausal range for the institution or underwent surgical sterilization (bilateral oophorectomy or hysterectomy).
* Women ≥50 years of age would be considered post-menopausal if they have been amenorrheic for 12 months or more following cessation of all exogenous hormonal treatments, had radiation-induced menopause with last menses \>1 year ago, had chemotherapy-induced menopause with last menses \>1 year ago, or underwent surgical sterilization (bilateral oophorectomy, bilateral salpingectomy or hysterectomy).
Exclusion Criteria:
* Performance Status ECOG \> 1
* Well differentiated GEPNETs grad 1 and 2 (except aggressive grade 2 tumours with a poor prognosis and a Ki67 \> 15%)
* Loco-regional treatment during the last 3 months involving all of the measurable lesions
* Chemotherapy during the last 8 weeks or longer until no persisting toxicity exists. Earlier treatment with mTORi or TKI the last 4 weeks or until no persisting toxicity exists
* Previous treatment with 177Lu-DOTA-TATE or cis-/carboplatin
* Other concomitant nephrotoxic treatment
* Serious heart disease (NYHA III-IV)
* Previous radiotherapy including \>25% of active bone marrow volume
* Pregnancy and lactation
* Extensive liver metastases combined with impaired liver function (i.e. abnormal laboratory parameters (\> grad 1 CTCAE) or ascites)
* Symptomatic CNS metastases (e.g. requiring corticosteroid treatment) Symptomatic treatment for meningiomas or corticosteroids due to treatment related swelling is however allowed
* Ongoing treatment with interferon. This treatment should be suspended a minimum of 4 wees before treatment with 177Lu-DOTA-TATE, or longer if there is persisting signs of toxicity
* Patients who have a another metastatic tumor diagnosis
* Known or expected hypersensitivity to 177Lu-DOTA-TATE, 68Ga- DOTA-TATE/TOC or any of their excipients
* History of psychiatric disease/condition that may interfere with the objectives and assessments of the study
* Female subjects who are pregnant or breastfeeding or subjects of reproductive potential who are not willing to employ effective birth control methods (Pearl index \<1) from screening to 6 months after the last dose of olaparib
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04375267
Study Brief:
Protocol Section:
NCT04375267