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Идёт набор NCT07171905

CAT-VHL Exploring the Role of Carbonic Anhydrase IX as Diagnostic and Theranostic Target in Von-Hippel Lindau Disease

Фаза II С лечением VHL - Von Hippel-Lindau Syndrome

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: investigating the role of CAIX as target in VHL disease and in VHL-/- tumors..
Кому может быть актуально
Состояния в реестре: VHL - Von Hippel-Lindau Syndrome. Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Италия
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Exploring the Role of Carbonic Anhydrase IX as Diagnostic and Theranostic Target in Von-hippel Lindau Disease

Обзор

The study is a phase 2, non-comparative and non-randomized, single arm, national clinical trial testing the hypothesis that CAIX-PET has diagnostic and theranostic potential in VHL disease and in VHL-/- tumors. Participants will receive a single dose of the diagnostic radiopharmaceutical \[89Zr\]Zr-DFO-Girentuximab and subsequently will be subjected to imaging with an hybrid PET/CT scanner. Sensitivity and diagnostic accuracy of experimental imaging will be assessed against standard of truth derived from standard of care procedures such as MRI or pathology following surgery. A theranostic approach will be simulated by replacing the physical decay of the diagnostic isotope \[89Zr\]Zr with the physical decay of therapeutic isotopes and evaluating tissue dosimetry.

Вмешательства

  • Препарат investigating the role of CAIX as target in VHL disease and in VHL-/- tumors.
    Participants VHL disease and in VHL-/- tumors, will receive a single dose of the diagnostic radiopharmaceutical \[89Zr\]Zr-DFO-Girentuximab and subsequently undergo imaging with a hybrid PET/CT scanner.

Первичные конечные точки

  • to assess the efficacy of CAIX-PET [Срок оценки: IMP administration at day 0; CAIX-PET from day 3 to 7; MRI according to standard of care and imaging assessment from day 1 to 60.]

Критерии участия

Критерии включения

  • Voluntarily given informed consent
  • Age ≥18 years old
  • Performance Status ECOG/WHO score 0-2
  • For females of reproductive potential, negative pregnancy test and use of highly effective contraception for 30 days following IMP administration
  • For males of reproductive potential, use of highly effective contraception for 30 days following IMP administration.

And, for the primary cohort:

  • Diagnosis of VHL disease requiring surveillance following confirmation of pathogenic variant at genetic test

Alternatively, for the secondary cohort:

\- Clinical and/or pathological diagnosis of hemangioblastoma, pheochromocytoma, pancreatic neuroendocrine tumor or clear cell renal cell carcinoma requiring surgery.

Критерии исключения

  • Performance Status ECOG/WHO score >2
  • Women who are pregnant or breastfeeding or are planning pregnancy during the study
  • Men who are planning fatherhood during the study
  • Exposure to any murine or chimeric antibodies within 5 years prior to the planned IMP administration
  • Exposure to any experimental diagnostic or therapeutic drug within 30 days from the planned IMP administration
  • Surgery, biopsy, ablative procedure, radiotherapy or any other local treatment for any primary tumor within 4 weeks prior to the planned IMP administration
  • Exposure to any systemic agent within 4 weeks prior to the planned IMP administration or in case of continuing adverse effects with grade >1 from such therapy
  • Current exposure to systemic agents or scheduled therapy in the next 6 months following the planned IMP administration
  • Serious non-malignant disease (e.g. psychiatric, infectious, autoimmune or metabolic) that may interfere with the objectives of the study or within the safety of compliance of the subjects as judged by the Investigator
  • Known hypersensitivity to \[89Zr\]Zr-DFO-Girentuximab or DFO (Desferrioxamine)
  • Severe chronic kidney disease with glomerular filtration rate ≤ 30 mL/min/1.73m2
  • Other vulnerable categories than rare disease (e.g, being in detention)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Не применимо
Модель
Одна группа
Маскирование
Открытое
Основная цель
Диагностика

Центры проведения

Италия · 1 центр
  • IRCCS Ospedale San Raffaele — Milan

Идентификаторы

NCT: NCT07171905 · PNRR-POC-2023-12377493

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗