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2024-516503-17-01Not yet recruitingPhase 3

Tandem therapy LutaPol/ltraPol ( I 77Lu / 90Y-DOTATATE) as an effective method in the treatment of neuroendocrine neoplasmas.

Source: EU CTIS (euclinicaltrials.eu) · Last updated 19 Aug 2026

Next steps

Brief summary (registry, in English)

The aim of the study is to develop an algorithm for the treatment of GEPNET patients using ItraPol and LutaPol isotope mixtures (177Lu-DOTATATE and 90Y-DOTATATE) based on personalized dosimetry.

Status (registry)
Not yet recruiting
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
92 (estimated)
First submitted
15 Nov 2024
Start date
20 Sept 2021
Lead sponsor
Narodowe Centrum Badan Jadrowych
EU CT number
2024-516503-17-01
EudraCT number
2020-006068-99

What you commit to

  • Study type: Interventional · Phase 3
  • Planned participants: 92
  • 4 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study design.

Who cannot take part

Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Cancer-related: Patient disability (Karnofsky <60) Expected survival of less than 6 months. Treatment for another malignancy less than 5 years prior to randomisation. Associated with current and past medical therapies and interventions: PRRT in the past. Chemotherapy or molecular treatment (for NEN or other cancer) in the past. Patient-related: Age under 18 years. Pregnancy or breastfeeding. Patients with impaired bladder outflow or untreated urinary incontinence without catheter protection. Lack of capacity to give informed consent to participate in the study. Failure to sign an informed consent form to participate in the study.

Who the study is looking for

  • Associated with neuroendocrine tumour: a)Presence of advanced, unresectable, histopathologically confirmed well and intermediate differentiated (G1 and G2) neuroendocrine tumour with high expression of somatostatin receptors on somatostatin receptor imaging (SRI) PET/CT with 68Ga-DOTA-TATE performed up to 12 weeks prior to first administration of therapy b)Detection of tumour progression according to RECIST criteria 1. 1 on multiphasic CT or dynamic MR imaging within 18 months, with a qualifying study performed up to 12 weeks prior to the first administration of therapy c)Laboratory tests*: ◦ Blood count with smear Hb > 9g/dl, platelets > 100,000/μl, leukocytes > 3,000/μl, neutrocytes > 1.5,000/μl, ◦ Creatinine <120 μmol/l (1.36 mg/dl) or eGFR>45 ml/min. ◦ ALT, AspAT, total bilirubin (values not exceeding 3x the reference standard) **it is acceptable to use for qualification the results of biochemical and haematological tests that are part of the medical history if they were performed up to 12 weeks before the qualifying visit and if, in the opinion of the investigator, there is no need and no indication to repeat them Patient-related: Patient's overall Karnofsky score ≥60%. Expected survival of more than 6 months. Age over 18 years, with no upper age limit. Ability to give informed consent to participate in the study. Signing an informed consent form to participate in the study.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on EU CTIS (euclinicaltrials.eu)

Sites (4)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki W KrakowieCracowPolandNot yet recruiting
Swietokrzyskie Centrum Onkologii Samodzielny Publiczny Zaklad Opieki Zdrowotnej w KielcachKielcePolandNot yet recruiting
Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut BadawczyWarsawPolandNot yet recruiting
Wojskowy Instytut Medyczny Panstwowy Instytut BadawczyWarsawPolandNot yet recruiting

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This page is information, not medical advice. Discuss any trial with your doctor.