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Идёт набор NCT05889312

Assessing Cancer Treatment Response to Therapy Using 18F-FSPG PET

— Наблюдательное Cancer Diagnosis Resistant Cancer Response, Acute Phase

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: 18F-FSPG PET/CT in NSCLC, 18F-FSPG PET/CT in HNSCC.
Кому может быть актуально
Состояния в реестре: Cancer, Diagnosis, Resistant Cancer, Response, Acute Phase. Базовые параметры: от 16 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
Великобритания
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

Improving Response Assessment in Cancer by Measurement of Cellular Redox Status Using 18F-FSPG Positron Emission Tomography

Обзор

Prospective single centre non-randomised exploratory observational study to measure changes in tumour cellular redox status with 18F-FSPG PET in stage 3 non-small cell lung cancer (NSCLC) and stage 3 and 4 head and neck squamous cell cancer (HNSCC) at baseline and during standard of care treatment, and to compare this with 18F-FDG PET/CT and RECIST 1.1 response at 12 weeks.

Подробное описание

Study design: Prospective single centre non-randomised exploratory observational study.

Number of patients: 32 (16 head and neck cancer, 16 lung cancer).

Primary hypothesis: Changes in 18F-FSPG uptake predict treatment efficacy.

Primary objectives: To measure changes in tumour cellular redox status with 18F-FSPG PET in stage 3 non-small cell lung cancer (NSCLC) and stage 3 and 4 head and neck squamous cell cancer (HNSCC) at baseline and during standard of care treatment, and to compare this with 18F-FDG PET/CT and RECIST 1.1 response at 12 weeks.

Secondary objectives: Characterise the uptake and pharmacokinetics of 18F-FSPG in NSCLC and HNSCC patients.

Determine the baseline level and variability of 18F-FSPG uptake within and between patients with NSCLC and HNSCC pre and post treatment.

Compare 18F-FSPG PET/CT imaging with standard measures of response (RECIST/PERCIST) and other clinical biomarkers (IHC and blood glutamate) at baseline and during cancer treatment.

Primary outcomes: Report and compare % change in 18F-FSPG uptake in NSCLC and HNSCC patients on standard of care treatment with standard measures of response (RECIST/PERCIST) Secondary outcomes: Report variation in 18F-FSPG uptake in NSCLC and HNSCC. Report kinetic data in 18F-FSPG uptake in NSCLC and HNSCC. Report correlation of 18F-FSPG uptake in NSCLC and HNSCC with available histology and blood markers.

Inclusion criteria:

1. Written informed consent 2. Aged 16 or above (as per NCRI) 3. Histologically confirmed NSCLC and HNSCC, who are treatment naïve and scheduled to commence standard of care treatment ((chemo)radiotherapy) 4. Willingness and ability to comply with scheduled study visits and tests 5. Confirmation of adequate function of all major organs and systems

Exclusion criteria :

1. Pregnant or lactating women 2. Concomitant uncontrolled medical conditions 3. Participants likely to require palliative radiotherapy within the first 12 weeks of treatment 4. Prognosis less than 3 months 5. Previous anti-cancer treatment (only treatment naïve patients eligible for inclusion)

Вмешательства

  • Диагностический тест 18F-FSPG PET/CT in NSCLC
    Stage 3 NSCLC with radical curative intent at baseline (pre-treatment) and at 4-8 weeks into treatment.
  • Диагностический тест 18F-FSPG PET/CT in HNSCC
    Stage 3 and 4 HNSCC with radical curative intent at baseline and at 2-4 weeks into treatment.

Первичные конечные точки

  • Changes in tumour cellular redox status [Срок оценки: 3 years]
Вторичные конечные точки (3)
  • 18F-FSPG kinetics [Срок оценки: 2 years]
  • 18F-FSPG heterogeneity [Срок оценки: 3 years]
  • Correlation with histopathology and blood biomarkers [Срок оценки: 3 years]

Критерии участия

Критерии включения

  • Written informed consent
  • Aged 16 or above
  • Histologically confirmed HNSCC or NSCLC, who are treatment naïve and scheduled to commence standard of care treatment ((chemo)radiotherapy)
  • Willingness and ability to comply with scheduled study visits and tests
  • Confirmation of adequate function of all major organs and systems

Критерии исключения

  • Pregnant or lactating women
  • Concomitant uncontrolled medical conditions
  • Participants likely to require palliative radiotherapy within the first 12 weeks of treatment
  • Prognosis less than 3 months
  • Previous anti-cancer treatment (only treatment naïve patients eligible for inclusion)

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Великобритания · 1 центр
  • Guy's and St Thomas' NHS Foundation Trust — London

Идентификаторы

NCT: NCT05889312 · 312860

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗