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Многоцентровое валидационное исследование [18F]AlF-FAPI-74 для ПЭТ-визуализации фибробластов, связанных с раком, с помощью ингибиторов белка активации фибробластов (FAPI) в различных типах опухолей (FAPIDO)

5 ноября 2026 г. обновлено: Christophe Deroose, Prof. Dr., KU Leuven

The aim of the project is to demonstrate superior detection ratio of [18F]AlF-FAPI-74 PET/CT compared to [18F]FDG PET/CT or conventional imaging in treatment-naïve, newly diagnosed patients with oesophagogastric adenocarcinoma (clinical T1-4N0-3M0) and pancreatic ductal adenocarcinoma (clinical T1-4N0-2M0-1) and describe the clinical utility of [18F]AlF-FAPI-74 PET/CT in oncological patients with a clinically challenging situation.

Обзор исследования

Статус

Рекрутинг

Условия

Вмешательство/лечение

Тип исследования

Интервенционный

Регистрация (Оцененный)

109

Фаза

  • Фаза 2
  • Фаза 3

Контакты и местонахождение

В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.

Места учебы

  • Бельгия
      • Edegem, Бельгия, 2650
        • Еще не набирают
        • University Hospital Antwerp (UZA)
        • Контакт:
          • Sigrid Stroobants, Prof. Dr.
        • Главный следователь:
          • Sigrid Stroobants, Prof. Dr.
      • Ghent, Бельгия, 9000
        • Рекрутинг
        • University Hospital Ghent
        • Контакт:
          • Karen Geboes, Prof. Dr.
          • Номер телефона: +32 9 332 05 30
          • Электронная почта: hiruz@uzgent.be
        • Главный следователь:
          • Karen Geboes, Prof. Dr.
      • Leuven, Бельгия, 3000
        • Рекрутинг
        • UZ Leuven
        • Контакт:
        • Главный следователь:
          • Christophe Deroose, Prof. Dr.

Критерии участия

Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.

Критерии приемлемости

Возраст, подходящий для обучения

18 лет и старше (Взрослый, Пожилой взрослый)

Принимает здоровых добровольцев

Нет

Полы, имеющие право на обучение

Все

Описание

Inclusion Criteria OGA:

  1. Voluntary written informed consent of the participant or their legally authorized representative has been obtained prior to any screening procedures.
  2. Age 18 or older.
  3. New histologic or cytologic proven diagnosis of oesophagogastric adenocarcinoma.
  4. Patient underwent a [18F]FDG PET/CT.
  5. TNM classification: cT1-4N0-3M0

Inclusion Criteria PDAC:

  1. Voluntary written informed consent of the participant or their legally authorized representative has been obtained prior to any screening procedures.
  2. Age 18 or older.
  3. New histologic or cytologic proven diagnosis of pancreatic ductal adenocarcinoma.
  4. Patient underwent a [18F]FDG PET/CT or conventional staging with CT or MRI.
  5. TNM classification: cT1-4N0-2M0-1, with the exception of upfront resectable patients.

Inclusion Criteria Clinically challenging cohort:

  1. Voluntary written informed consent of the participant or their legally authorized representative has been obtained prior to any screening procedures.
  2. Age 18 or older.
  3. Histologic or cytologic proven diagnosis of a malignancy.
  4. Patient underwent a [18F]FDG PET/CT.
  5. Unexplained symptoms, complaints, biochemical or imaging (scintigraphy, PET, CT, MR) findings.

Exclusion Criteria:

  1. Participant is mentally or legally incapacitated, doesn't understand the study design or is not willing or capable to undergo all study-specific procedures.
  2. Any disorder or condition, which in the Investigator's opinion might jeopardise the participant's safety or compliance with the protocol.
  3. Any prior or concomitant treatment(s) that might jeopardise the participant's safety or that would compromise the integrity of the Trial.
  4. Female who is pregnant (urinary hCG test can be performed in case of doubt), breast-feeding or intends to become pregnant or is of child-bearing potential and not using an adequate, highly effective contraceptive (with a relatively high Pearl Index: natural methods, minipill outside postpartum period, spermicides or condoms in monotherapy or no usage of contraception when sexually active are not accepted).
  5. Participation in an interventional Trial with an investigational medicinal product (IMP) or device when the trial designs are not considered compatible by the study team.
  6. Participation in a clinical scientific study in the last 12 months with a radiation exposure caused by the experimental procedures greater than 1 mSv.
  7. Participant has a known hypersensitivity to [18F]AlF-FAPI-74 or the used excipients.

Учебный план

В этом разделе представлена ​​подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.

Как устроено исследование?

Детали дизайна

  • Основная цель: Диагностика
  • Распределение: Нерандомизированный
  • Интервенционная модель: Одногрупповое задание
  • Маскировка: Нет (открытая этикетка)

Оружие и интервенции

Группа участников / Армия
Вмешательство/лечение
Экспериментальный: Аденокарцинома пищевода и желудка (ОГА)
Диагностический тест: [18F]AlF-FAPI-74 PET/CT

A [18F]AlF-FAPI-74 PET/CT will be performed at the same site of the screening visit (UZ Leuven, UZ Gent or UZ Antwerpen). Subjects are required to be sober four hours before the scan. The patient will get an IV line, through which the [18F]AlF-FAPI-74 will be injected in one bolus (3,5 MBq/kg). After 60 minutes, the acquisition on the PET/CT scan will take place. The CT will be a low dose CT with oral contrast. After the scan, participants will be observed at the department in case of adverse events. During this time, the participant can fill in the PRO. The estimated duration of this visit is three hours. If the patient receives neo-adjuvant therapy, a second [18F]AlF-FAPI-74 PET/CT will be performed maximum one month before surgery. If the planned surgery gets postponed after the second [18F]AlF-FAPI-74 PET/CT has been performed, we will have the possibility to perform one additional (i.e. third) [18F]AlF-FAPI-74 PET/CT, before the final surgery.
Экспериментальный: Аденокарцинома протоков поджелудочной железы (PDAC)
Диагностический тест: [18F]AlF-FAPI-74 PET/CT

A [18F]AlF-FAPI-74 PET/CT will be performed at the same site of the screening visit (UZ Leuven, UZ Gent or UZ Antwerpen). Subjects are required to be sober four hours before the scan. The patient will get an IV line, through which the [18F]AlF-FAPI-74 will be injected in one bolus (3,5 MBq/kg). After 60 minutes, the acquisition on the PET/CT scan will take place. The CT will be a low dose CT with oral contrast. After the scan, participants will be observed at the department in case of adverse events. During this time, the participant can fill in the PRO. The estimated duration of this visit is three hours. If the patient receives neo-adjuvant therapy, a second [18F]AlF-FAPI-74 PET/CT will be performed maximum one month before surgery. If the planned surgery gets postponed after the second [18F]AlF-FAPI-74 PET/CT has been performed, we will have the possibility to perform one additional (i.e. third) [18F]AlF-FAPI-74 PET/CT, before the final surgery.
Экспериментальный: Клинически сложные ситуации
Диагностический тест: [18F]AlF-FAPI-74 PET/CT

A [18F]AlF-FAPI-74 PET/CT will be performed at the same site of the screening visit (UZ Leuven, UZ Gent or UZ Antwerpen). Subjects are required to be sober four hours before the scan. The patient will get an IV line, through which the [18F]AlF-FAPI-74 will be injected in one bolus (3,5 MBq/kg). After 60 minutes, the acquisition on the PET/CT scan will take place. The CT will be a low dose CT with oral contrast. After the scan, participants will be observed at the department in case of adverse events. During this time, the participant can fill in the PRO. The estimated duration of this visit is three hours. If the patient receives neo-adjuvant therapy, a second [18F]AlF-FAPI-74 PET/CT will be performed maximum one month before surgery. If the planned surgery gets postponed after the second [18F]AlF-FAPI-74 PET/CT has been performed, we will have the possibility to perform one additional (i.e. third) [18F]AlF-FAPI-74 PET/CT, before the final surgery.

Что измеряет исследование?

Первичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
Primary Objective OGA: demonstrate superiority of [18F]AlF-FAPI-74 PET/CT over [18F]FDG PET/CT.
Временное ограничение: From enrollment to the end of the follow-up period (i.e. 12 months after first [18F]AlF-FAPI-74 PET/CT)

Detection ratio for lymph node and distant metastases (combined).
From enrollment to the end of the follow-up period (i.e. 12 months after first [18F]AlF-FAPI-74 PET/CT)
Primary Objective PDAC: demonstrate superiority of [18F]AlF-FAPI-74 PET/CT over conventional imaging (CT or MRI) or [18F]FDG PET/CT (if available)
Временное ограничение: From enrollment to the end of the follow-up period (i.e. 12 months after first [18F]AlF-FAPI-74 PET/CT)

Detection ratio for lymph node and distant metastases (combined).
From enrollment to the end of the follow-up period (i.e. 12 months after first [18F]AlF-FAPI-74 PET/CT)
Primary Objective Clinically Challenging Situation: demonstrate contribution of [18F]AlF-FAPI-74 PET/CT in this setting.
Временное ограничение: From enrollment to the end of the follow-up period (i.e. 12 months after first [18F]AlF-FAPI-74 PET/CT)

Fraction of patients were scan was deemed contributory. This means:

  1. [18F]AlF-FAPI-74 identifies a lesion as malignant (true positive) with effective upstaging.
  2. [18F]AlF-FAPI-74 identifies a lesion as non-malignant (true negative) with effective downstaging.
  3. [18F]AlF-FAPI-74 can differentiate between a malignant or non-malignant lesion when there is doubt.
  4. Other implications that are deemed contributory by the treating physician.
From enrollment to the end of the follow-up period (i.e. 12 months after first [18F]AlF-FAPI-74 PET/CT)

Вторичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
OGA & PDAC: Detection ratio for tumor detection
Временное ограничение: From enrollment to the end of the follow-up period (i.e. 12 months after first [18F]AlF-FAPI-74 PET/CT)

primary tumor alone; lymph nodes alone (N-staging); distant metastases alone (M-staging) and lymph node + distant metastases combined (with inclusion of patients without N- or M-lesions).
From enrollment to the end of the follow-up period (i.e. 12 months after first [18F]AlF-FAPI-74 PET/CT)
OGA & PDAC: specificity, positive and negative predictive value and accuracy
Временное ограничение: From enrollment to the end of the follow-up period (i.e. 12 months after first [18F]AlF-FAPI-74 PET/CT)

Specificity, positive predictive value, negative predictive value, accuracy for lymph node and distant metastases (combined); for detection of primary tumor; for lymph nodes alone (N-staging); for distant metastases alone (M-staging).
From enrollment to the end of the follow-up period (i.e. 12 months after first [18F]AlF-FAPI-74 PET/CT)
OGA & PDAC: positive and negative likelihood ratios; diagnostic odds ratio.
Временное ограничение: From enrollment to the end of the follow-up period (i.e. 12 months after first [18F]AlF-FAPI-74 PET/CT)

Positive and negative likelihood ratios; diagnostic odds ratio.
From enrollment to the end of the follow-up period (i.e. 12 months after first [18F]AlF-FAPI-74 PET/CT)
OGA & PDAC: semi-quantitative uptake measurements
Временное ограничение: From enrollment to the end of the follow-up period (i.e. 12 months after first [18F]AlF-FAPI-74 PET/CT)

Semi-quantitative uptake measurements (maximal standardized uptake value (SUVmax), average SUV (SUVmean), peak SUV (SUVpeak) of tumoral lesions on [18F]AlF-FAPI-74 PET/CT and [18F]FDG PET/CT.
From enrollment to the end of the follow-up period (i.e. 12 months after first [18F]AlF-FAPI-74 PET/CT)
OGA & PDAC: tumor-to-background uptake values
Временное ограничение: From enrollment to the end of the follow-up period (i.e. 12 months after first [18F]AlF-FAPI-74 PET/CT)

Tumor-to-background uptake values (TBR; SUV lesion divided by SUV background) for [18F]AlF-FAPI-74 PET/CT and [18F]FDG PET/CT, using following background organs: liver, lung, gluteus muscle, mediastinal bloodpool, bowel, bone marrow (L4 if no abnormal uptake).
From enrollment to the end of the follow-up period (i.e. 12 months after first [18F]AlF-FAPI-74 PET/CT)
OGA & PDAC: impact on TNM stage
Временное ограничение: From enrollment to the end of the follow-up period (i.e. 12 months after first [18F]AlF-FAPI-74 PET/CT)

Impact on TNM stage of [18F]AlF-FAPI-74 PET/CT compared to full staging ([18F]FDG PET/CT and conventional imaging) and impact of [18F]AlF-FAPI-74 PET/CT compared to only conventional imaging-based staging.
From enrollment to the end of the follow-up period (i.e. 12 months after first [18F]AlF-FAPI-74 PET/CT)
OGA & PDAC: impact on clinical management
Временное ограничение: From enrollment to the end of the follow-up period (i.e. 12 months after first [18F]AlF-FAPI-74 PET/CT)

Impact on clinical management.
From enrollment to the end of the follow-up period (i.e. 12 months after first [18F]AlF-FAPI-74 PET/CT)
OGA & PDAC: impact on potential radiation therapy plan
Временное ограничение: From enrollment to the end of the follow-up period (i.e. 12 months after first [18F]AlF-FAPI-74 PET/CT)

Impact on potential radiation therapy plan.
From enrollment to the end of the follow-up period (i.e. 12 months after first [18F]AlF-FAPI-74 PET/CT)
OGA & PDAC: psychological impact
Временное ограничение: From enrollment to the end of the follow-up period (i.e. 12 months after first [18F]AlF-FAPI-74 PET/CT)

Psychological impact on patient of [18F]AlF-FAPI-74 PET/CT procedure.
From enrollment to the end of the follow-up period (i.e. 12 months after first [18F]AlF-FAPI-74 PET/CT)
OGA & PDAC: reproducibility
Временное ограничение: From enrollment to the end of the follow-up period (i.e. 12 months after first [18F]AlF-FAPI-74 PET/CT)

Intra- and interobserver reproducibility of both [18F]FDG and [18F]AlF-FAPI-74 PET/CT.
From enrollment to the end of the follow-up period (i.e. 12 months after first [18F]AlF-FAPI-74 PET/CT)
OGA & PDAC: adverse events
Временное ограничение: From enrollment to the end of the follow-up period (i.e. 12 months after first [18F]AlF-FAPI-74 PET/CT)

Patient safety: adverse events of [18F]AlF-FAPI-74 PET/CT.
From enrollment to the end of the follow-up period (i.e. 12 months after first [18F]AlF-FAPI-74 PET/CT)
OGA & PDAC: evolution between baseline and end of neo-adjuvant treatment
Временное ограничение: From enrollment to the end of the follow-up period (i.e. 12 months after first [18F]AlF-FAPI-74 PET/CT)

Evolution between baseline and end of neo-adjuvant treatment in patients with 2 [18F]AlF-FAPI-74 scans: (i) number of lesion; (ii) uptake; (iii) TBR; (iv) TNM score;(v) treatment plan based on scan.
From enrollment to the end of the follow-up period (i.e. 12 months after first [18F]AlF-FAPI-74 PET/CT)
OGA & PDAC: correlation with immunohistochemistry
Временное ограничение: From enrollment to the end of the follow-up period (i.e. 12 months after first [18F]AlF-FAPI-74 PET/CT)

Correlation of [18F]AlF-FAPI-74 biodistribution with FAP tissue expression as measured by immunohistochemistry (IHC).
From enrollment to the end of the follow-up period (i.e. 12 months after first [18F]AlF-FAPI-74 PET/CT)
Subgroup analysis OGA: lymph node detection
Временное ограничение: From enrollment to the end of the follow-up period (i.e. 12 months after first [18F]AlF-FAPI-74 PET/CT)

Subgroup 1: Upfront resectable patients. Subgroup 2: Patients scheduled for neo-adjuvant therapy (mostly classified as locally advanced).

Sensitivity, specificity, postivie predictive value, negative predictive value for lymph nodes.
From enrollment to the end of the follow-up period (i.e. 12 months after first [18F]AlF-FAPI-74 PET/CT)
Subgroup analysis OGA: impact on TNM stage
Временное ограничение: From enrollment to the end of the follow-up period (i.e. 12 months after first [18F]AlF-FAPI-74 PET/CT)

Subgroup 1: Upfront resectable patients. Subgroup 2: Patients scheduled for neo-adjuvant therapy (mostly classified as locally advanced).

Impact on TNM stage of [18F]AlF-FAPI-74 PET/CT compared to [18F]FDG PET/CT-based stage.
From enrollment to the end of the follow-up period (i.e. 12 months after first [18F]AlF-FAPI-74 PET/CT)
Subgroup analysis OGA: evolution between baseline and end of neo-adjuvant treatment
Временное ограничение: From enrollment to the end of the follow-up period (i.e. 12 months after first [18F]AlF-FAPI-74 PET/CT)

Subgroup 2: Patients scheduled for neo-adjuvant therapy (mostly classified as locally advanced).

Evolution between baseline and end of neo-adjuvant treatment in patients with 2 [18F]AlF-FAPI-74 scans: (i) number of lesion; (ii) uptake; (iii) TBR; (iv) TNM score; (v) treatment plan based on scan
From enrollment to the end of the follow-up period (i.e. 12 months after first [18F]AlF-FAPI-74 PET/CT)
Subgroup analysis OGA: correlation with pathology
Временное ограничение: From enrollment to the end of the follow-up period (i.e. 12 months after first [18F]AlF-FAPI-74 PET/CT)

Subgroup 2: Patients scheduled for neo-adjuvant therapy (mostly classified as locally advanced).

Correlation of imaging parameters and their change with pathological assessment of resection specimen (pTNM stage, regression grade).
From enrollment to the end of the follow-up period (i.e. 12 months after first [18F]AlF-FAPI-74 PET/CT)
Subgroup analysis PDAC: tumor detection
Временное ограничение: From enrollment to the end of the follow-up period (i.e. 12 months after first [18F]AlF-FAPI-74 PET/CT)

Subgroup 1: Patients scheduled for neo-adjuvant therapy (mostly classified as borderline resectable or locally advanced).

Subgroup 2: Metastatic patients. Sensitivity, specificity, positive predictive value, negative predictive value and accuracy for lymph nodes and distant metastases.
From enrollment to the end of the follow-up period (i.e. 12 months after first [18F]AlF-FAPI-74 PET/CT)
Subgroup analysis PDAC: impact on TNM stage
Временное ограничение: From enrollment to the end of the follow-up period (i.e. 12 months after first [18F]AlF-FAPI-74 PET/CT)

Subgroup 1: Patients scheduled for neo-adjuvant therapy (mostly classified as borderline resectable or locally advanced).

Subgroup 2: Metastatic patients. Impact on TNM stage of [18F]AlF-FAPI-74 PET/CT compared to [18F]FDG PET/CT, CT or MRI-based stage.
From enrollment to the end of the follow-up period (i.e. 12 months after first [18F]AlF-FAPI-74 PET/CT)
Subgroup analysis PDAC: evolution between baseline and end of neo-adjuvant treatment
Временное ограничение: From enrollment to the end of the follow-up period (i.e. 12 months after first [18F]AlF-FAPI-74 PET/CT)

Subgroup 1: Patients scheduled for neo-adjuvant therapy (mostly classified as borderline resectable or locally advanced).

Evolution between baseline and end of neo-adjuvant treatment in patients with 2 [18F]AlF-FAPI-74 scans: (i) number of lesion; (ii) uptake; (iii) TBR; (iv) TNM score; (v) treatment plan based on scan
From enrollment to the end of the follow-up period (i.e. 12 months after first [18F]AlF-FAPI-74 PET/CT)
Subgroup analysis PDAC: correlation with pathology
Временное ограничение: From enrollment to the end of the follow-up period (i.e. 12 months after first [18F]AlF-FAPI-74 PET/CT)

Subgroup 1: Patients scheduled for neo-adjuvant therapy (mostly classified as borderline resectable or locally advanced).

Correlation of imaging parameters and their change with pathological assessment of resection specimen (pTNM stage, regression grade).
From enrollment to the end of the follow-up period (i.e. 12 months after first [18F]AlF-FAPI-74 PET/CT)
Subgroup analysis PDAC: association with survival
Временное ограничение: From enrollment to the end of the follow-up period (i.e. 12 months after first [18F]AlF-FAPI-74 PET/CT)

Subgroup 2: Metastatic patients. Association between total tumor burden on [18F]AlF-FAPI-74 PET/CT and survival. Association between semi-quantitative uptake measurements (maximal standardized uptake value (SUVmax), average SUV (SUVmean), peak SUV (SUVpeak) of tumoral lesions on [18F]AlF-FAPI-74 PET/CT and survival.
From enrollment to the end of the follow-up period (i.e. 12 months after first [18F]AlF-FAPI-74 PET/CT)
Clinically Challenging Situation: detection rate
Временное ограничение: From enrollment to the end of the follow-up period (i.e. 12 months after first [18F]AlF-FAPI-74 PET/CT)

Primary tumor/local recurrence, lymph node and distant metastases detection rate (compared to best value comparator) vs. [18F]FDG PET/CT.
From enrollment to the end of the follow-up period (i.e. 12 months after first [18F]AlF-FAPI-74 PET/CT)
Clinically Challenging Situation: semi-quantitative uptake measurements
Временное ограничение: From enrollment to the end of the follow-up period (i.e. 12 months after first [18F]AlF-FAPI-74 PET/CT)

Semi-quantitative uptake measurements (maximal standardized uptake value (SUVmax), average SUV. (SUVmean), peak SUV (SUVpeak)) of tumoral lesions on [18F]AlF-FAPI-74 PET/CT and [18F]FDG PET/CT
From enrollment to the end of the follow-up period (i.e. 12 months after first [18F]AlF-FAPI-74 PET/CT)
Clinically Challenging Situation: tumor-to-background uptake values
Временное ограничение: From enrollment to the end of the follow-up period (i.e. 12 months after first [18F]AlF-FAPI-74 PET/CT)

Tumor-to-background uptake values (SUV lesion divided by SUV background) on [18F]AlF-FAPI-74 PET/CT and [18F]FDG PET/CT, using following background organs: liver, lung, gluteus muscle, mediastinal bloodpool, bowel, bone marrow (L4 if no abnormal uptake).
From enrollment to the end of the follow-up period (i.e. 12 months after first [18F]AlF-FAPI-74 PET/CT)
Clinically Challenging Situation: impact on potential radiation therapy plan
Временное ограничение: From enrollment to the end of the follow-up period (i.e. 12 months after first [18F]AlF-FAPI-74 PET/CT)

Impact on potential radiation therapy plan of [18F]AlF-FAPI-74 PET/CT vs. [18F]FDG PET/CT.
From enrollment to the end of the follow-up period (i.e. 12 months after first [18F]AlF-FAPI-74 PET/CT)
Clinically Challenging Situation: reproducibility
Временное ограничение: From enrollment to the end of the follow-up period (i.e. 12 months after first [18F]AlF-FAPI-74 PET/CT)

Intra- and interobserver reproducibility.
From enrollment to the end of the follow-up period (i.e. 12 months after first [18F]AlF-FAPI-74 PET/CT)
Clinically Challenging Situation: adverse events
Временное ограничение: From enrollment to the end of the follow-up period (i.e. 12 months after first [18F]AlF-FAPI-74 PET/CT)

Patient safety: adverse events.
From enrollment to the end of the follow-up period (i.e. 12 months after first [18F]AlF-FAPI-74 PET/CT)

Соавторы и исследователи

Здесь вы найдете людей и организации, участвующие в этом исследовании.

Спонсор

KU Leuven

Соавторы

Universitaire Ziekenhuizen KU Leuven
University Hospital, Ghent
University Hospital, Antwerp
Kom Op Tegen Kanker

Даты записи исследования

Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.

Изучение основных дат

Начало исследования (Действительный)

6 февраля 2025 г.

Первичное завершение (Оцененный)

1 декабря 2027 г.

Завершение исследования (Оцененный)

1 декабря 2027 г.

Даты регистрации исследования

Первый отправленный

6 января 2025 г.

Впервые представлено, что соответствует критериям контроля качества

14 января 2025 г.

Первый опубликованный (Действительный)

17 января 2025 г.

Обновления учебных записей

Последнее опубликованное обновление (Действительный)

6 ноября 2026 г.

Последнее отправленное обновление, отвечающее критериям контроля качества

5 ноября 2026 г.

Последняя проверка

1 марта 2026 г.

Дополнительная информация

Термины, связанные с этим исследованием

Ключевые слова

Дополнительные соответствующие термины MeSH

Другие идентификационные номера исследования

  • S67792
  • 2024-512059-19 (Номер EudraCT)

Планирование данных отдельных участников (IPD)

Планируете делиться данными об отдельных участниках (IPD)?

НЕТ

Информация о лекарствах и устройствах, исследовательские документы

Изучает лекарственный продукт, регулируемый FDA США.

Нет

Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.

Нет

Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .

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