Actively Recruiting
"Receptor Radionuclide Therapy With 177Lu-DOTATOC
Led by Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS · Updated on 2024-08-13
100
Participants Needed
2
Research Sites
172 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Peptide receptor radionuclide therapy (PRRT) may be recommended in G1- G2 GEP-NET patients with disease progression on somatostatine analogues therapy (LUTATHERA®). However, there are several diseases, including neuroendocrine neoplasia not originating from the digestive tract, for which the efficacy of PRRT has already been demonstrated, but which are not currently within the indications of LUTATHERA and therefore cannot benefit from it (i.e. bronchopulmonary, ovarian, renal NETs and neuroendocrine carcinomas). Moreover, the role of PRRT is also accepted in Pheochromocytomas and paragangliomas (PPGLs), Meningiomas, but also as a salvage therapy in pre-treated NET pts, and other SSTR-positive malignancies (Lymphomas, Gliomas…). Least explored among radiopharmaceuticals for SSTR-positive tumors is 177Lu-DOTATOC. This study aims to investigate the efficacy and safety of lutetium (177Lu) edotreotide (Lu-Dotatoc) on all the above-mentioned diseases that could benefit from receptor radionuclide therapy. We believe that this study, which will involve only patients outside the indication of LUTATHERA, will expand the current knowledge of radionuclide receptor therapy with 177Lu- DOTATOC, particularly with regard to objective response and safety parameters, and may consolidate its in the management of these diseases.
CONDITIONS
Official Title
"Receptor Radionuclide Therapy With 177Lu-DOTATOC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Histological or cytological confirmation of neuroendocrine tumors or other tumor types documented as SSTR2-positive that may benefit from receptor radionuclide therapy
- Measurable or evaluable disease according to RECIST 1.1 criteria
- Any disease stage allowed with significant tumor uptake (Grade 3 or 4) on 68Ga PET/CT imaging
- Disease progression within the last 12 months despite conventional treatments
- Patients with or without concurrent somatostatin analog therapy at stable dose
- Life expectancy greater than 6 months
- ECOG performance status less than 2
- Adequate hematological, liver, and renal function
- Use of highly effective birth control methods for those of childbearing potential
- Willingness and ability to give informed consent
You will not qualify if you...
- Chemotherapy or therapeutic radiotherapy within 4 weeks prior to study or palliative radiotherapy within 2 weeks
- Known hypersensitivity to lutetium-177, edotreotide, DOTA, or related compounds
- Hypersensitivity to lysine, arginine, or nephroprotective amino acid excipients
- Prior external beam radiation therapy to more than 25% of bone marrow
- Previous PRRT exceeding kidney or bone marrow dose limits
- Patients eligible for LUTATHERA treatment
- Unresolved acute toxic effects from prior therapies greater than grade 1
- ECOG performance status greater than 2
- Participation in another investigational clinical trial within 30 days prior to screening
- Uncontrolled illness including active infection, heart failure, unstable angina, arrhythmia, or psychiatric/social conditions limiting compliance
- Pregnant or breastfeeding women
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
AUSL Romagna - Ospedale "M. Bufalini"
Cesena, Forlì-Cesena, Italy, 47521
Not Yet Recruiting
2
IRCCS Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori" - IRST S.r.l.
Meldola, Forlì-Cesena, Italy, 47014
Actively Recruiting
Research Team
O
Oriana Nanni
CONTACT
B
Bernadette Vertogen
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
2
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