Clinical trial · Observational
Italian Multicenter Experience With Radioreceptor-assisted Therapy (PRRT)
Italian Multicenter Experience With Radioreceptor-assisted Therapy (PRRT) in Pheochromocytomas and Paragangliomas: a Retrospective Analysis
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This multicenter retrospective Italian study evaluates the efficacy and safety of PRRT in patients with advanced, unresectable or metastatic pheochromocytomas and paragangliomas (PPGL). Data from \~210 patients treated between 2000 and 2024 will be analyzed. The primary endpoint is disease control rate (DCR). Secondary endpoints include progression-free survival (PFS), overall survival (OS), and prognostic factors.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Paragangliomas | Paraganglioma | ALIAS | 0.90 |
| Pheochromocytomas | Adrenal Gland Pheochromocytoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Peptide Receptor Radionuclide Therapy (PRRT) | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- label
- MONO 177Lu
- description
- Patients treated with PRRT using ¹⁷⁷Lu only.
- interventionNames
- Radiation: Peptide Receptor Radionuclide Therapy (PRRT)
- label
- MONO 90Y
- description
- Patients treated with PRRT using ⁹⁰Y only.
- interventionNames
- Radiation: Peptide Receptor Radionuclide Therapy (PRRT)
- label
- TANDEM 177Lu + 90Y
- description
- Patients treated with PRRT using a combination (sequential or concomitant) of ¹⁷⁷Lu and ⁹⁰Y.
- interventionNames
- Radiation: Peptide Receptor Radionuclide Therapy (PRRT)
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Documented diagnosis of pheochromocytoma or paraganglioma (PPGL) (sporadic or hereditary forms) with unresectable or metastatic disease. * Treatment with peptide receptor radionuclide therapy (PRRT) administered with ⁷⁷Lu and/or ⁹⁰Y (including combination regimens), with t0 (first PRRT administration) between January 1, 2000 and February 28, 2024. * Availability of essential data required by the protocol to document exposure (PRRT) and outcomes, including: PRRT start date (t0) and treatment details (radioisotope(s), number of cycles and/or cycles actually administered, intervals when available), At least one post-treatment evaluation suitable for determining disease control rate (DCR) (morphological imaging by CT/MRI ± functional imaging by PET/CT, and available clinical data), Follow-up information suitable for determining progression-free survival (PFS) within the predefined time window. * Availability of follow-up up to 12 months from end of treatment (EoT), or documentation of progression and/or death occurring within 12 months. * Required data and source documents are available at the enrolling center or obtainable from other Italian centers (e.g., PRRT-administering center or centers performing imaging/evaluations) through formal data transfer agreements (e.g., DTA) in compliance with applicable regulations. * Privacy/consent requirements (general framework): For living and contactable patients, consent for personal data processing will be managed according to the requirements/assessment of the Ethics Committee. For deceased or non-contactable patients after reasonable documented efforts, inclusion may occur without consent, as it falls under situations of "impossibility to inform the subjects," in accordance with applicable regulations (Article 110 of the Italian Privacy Code and subsequent amendments), subject to Ethics Committee evaluation/opinion and implementation of appropriate safeguards. Exclusion Criteria: * Patients who did not receive at least one cycle of peptide receptor radionuclide therapy (PRRT).
References
Publications (5)
- BACKGROUNDSu D, Yang H, Qiu C, Chen Y. Peptide receptor radionuclide therapy in advanced Pheochromocytomas and Paragangliomas: a systematic review and meta-analysis. Front Oncol. 2023 Jul 6;13:1141648. doi: 10.3389/fonc.2023.1141648. eCollection 2023. PMID 37483516
- BACKGROUNDAygun N, Uludag M. Pheochromocytoma and Paraganglioma: From Epidemiology to Clinical Findings. Sisli Etfal Hastan Tip Bul. 2020 Jun 3;54(2):159-168. doi: 10.14744/SEMB.2020.18794. eCollection 2020. PMID 32617052
- BACKGROUNDSaavedra T JS, Nati-Castillo HA, Valderrama Cometa LA, Rivera-Martinez WA, Asprilla J, Castano-Giraldo CM, Sanchez S L, Heredia-Espin M, Arias-Intriago M, Izquierdo-Condoy JS. Pheochromocytoma: an updated scoping review from clinical presentation to management and treatment. Front Endocrinol (Lausanne). 2024 Dec 13;15:1433582. doi: 10.3389/fendo.2024.1433582. eCollection 2024. PMID 39735644
- BACKGROUNDCascon A, Calsina B, Monteagudo M, Mellid S, Diaz-Talavera A, Curras-Freixes M, Robledo M. Genetic bases of pheochromocytoma and paraganglioma. J Mol Endocrinol. 2023 Jan 24;70(3):e220167. doi: 10.1530/JME-22-0167. Print 2023 Apr 1. PMID 36520714
- BACKGROUNDWelander J, Soderkvist P, Gimm O. Genetics and clinical characteristics of hereditary pheochromocytomas and paragangliomas. Endocr Relat Cancer. 2011 Dec 1;18(6):R253-76. doi: 10.1530/ERC-11-0170. Print 2011 Dec. PMID 22041710