Radioreceptor therapy with labeled somatostatin analogues in tumors with high expression of somatostatin receptors.

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

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2013-002605-65-IT

Enrollment

100

Registered

2013-10-02

Start date

2013-11-26

Completion date

Unknown

Last updated

2025-01-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients with tumors expressing somatostatin receptors.

Interventions

Product Name: Analogo Somatostatina marcato con 90Yttrium- DOTA (Tyr3)- octreotate 177 Lutetium DOTA (Tyr3) Product Code: NA Pharmaceutical Form: Kit for radiopharmaceutical preparation INN or Propos

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 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 2500/µL, platelets> 90000/µL; hemoglobin> 9 g / dL, creatinine =65 years) yes F.1.3.1 Number of subjects for this age range 50

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

Measure	Time frame
Main Objective: Correlate the dosimetric results of each lesion "target" with the response of the lesion to the radioreceptor therapy (PRRT) in patients with cyto-histological diagnosis of cancer or other neuroendocrine tumors expressing somatostatin receptors.;Secondary Objective: Correlate the dosimetric results of BED to the kidney and dose to the spinal forecast with nephrotoxicity and hematologic toxicity determined by the PRRT.;Primary end point(s): Assess for all patients undergoing PRRT survival at 3 and 6 months, the PFS and ORR. ;Timepoint(s) of evaluation of this end point: 3 and 6 months.	—

Measure

Time frame

Main Objective: Correlate the dosimetric results of each lesion "target" with the response of the lesion to the radioreceptor therapy (PRRT) in patients with cyto-histological diagnosis of cancer or other neuroendocrine tumors expressing somatostatin receptors.;Secondary Objective: Correlate the dosimetric results of BED to the kidney and dose to the spinal forecast with nephrotoxicity and hematologic toxicity determined by the PRRT.;Primary end point(s): Assess for all patients undergoing PRRT survival at 3 and 6 months, the PFS and ORR. ;Timepoint(s) of evaluation of this end point: 3 and 6 months.

—

Secondary

Measure	Time frame
Secondary end point(s): Correlate the response to PRRT with the degree of histological differentiation at the time of diagnosis and the stage of disease at enrollment in this clinical study.;Timepoint(s) of evaluation of this end point: 3 and 6 months.	—

Countries

Italy

Contacts

Public ContactS.C. di Medicina Nucleare

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

annibale.versari@asmn.re.it00390522296313

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026