Radioreceptor therapy with labeled somatostatin analogues in tumors with high expression of somatostatin receptors. - DOTA2013/DOTATER

Azienda Ospedaliera di Reggio Emilia Arcispedale S.Maria Nuova/IRCCS0 个研究点开始时间: 2013年10月2日最近更新: 2014年2月17日

适应症

试验速览

暂无简介。

•Patients age > 18 years old and either gender or ethnicity
•Cyto-histological diagnosis of NET or other SSTR-positive tumors (brain tumor cancer, colon cancer, differentiated thyroid carcinoma, lymphoma, breast cancer, melanoma, lung cancer, renal cancer, sarcoma, prostate cancer, hepatocellular carcinoma, thymic neoplasms)
•Presence of at least one measurable lesion> 1 cm
•High expression of somatostatin receptors in the 68Ga-SST-A PET / CT in / lesion and / i target. It is defined as high expression of somatostatin receptors demonstration examination 68Ga-SST-A PET / CT (semi-quantitative analysis) in a ratio of SUVmax tumor / muscle SUVmean> 4:1.
•Examination CT with contrast or MRI <2 months of enrollment in this clinical study
•Adequate serum chemistry values: white blood cell count> 2500/µL, platelets> 90000/µL; hemoglobin> 9 g / dL, creatinine <2 mg / dl, bilirubin <2.5 mg / dL
•ECOG performance status = 2
•Written informed consent
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 50
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 50

•Pregnancy status
•In case of breastfeeding, refuse to stop breastfeeding
•Surgery, chemotherapy, radiation therapy, or biological drugs in the 4 weeks preceding the PRRT (except radiotherapy with palliative intent of symptomatic lesions in patients plurimetastatici).
•Participation in another clinical protocol experimental therapy within 4 weeks before the PRRT
•Invasion of bone marrow disease ascertained> 25%
•Patients with other therapeutic option validated as an effective
•Life expectancy <6 months

发起方

Azienda Ospedaliera di Reggio Emilia Arcispedale S.Maria Nuova/IRCCS