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Идёт набор NCT03604315

Serial Imaging of the Novel Radiotracer [^18F] FLuorthanatrace ([^18F] FTT) by PET/CTF

Фаза I С лечением Breast Carcinoma Fallopian Tube Carcinoma Ovarian Carcinoma Primary Peritoneal Carcinoma

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: Computed Tomography, Computed Tomography, Fludeoxyglucose F-18, Fluorine F 18 Fluorthanatrace.
Кому может быть актуально
Состояния в реестре: Breast Carcinoma, Fallopian Tube Carcinoma, Ovarian Carcinoma, Primary Peritoneal Carcinoma. Базовые параметры: от 18 лет · Женщины.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США
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

Serial Imaging of the Novel Radiotracer [^18F] FLuorthanatrace ([^18F] FTT) by PET/CT

Обзор

This phase I trial studies how well fluorine F 18 fluorthanatrace positron emission tomography (PET)/computed tomography (CT) works in patients with solid tumors. Fluorine F 18 fluorthanatrace is a radioactive tracer, a type of imaging agent that is labeled with a radioactive tag and injected into the body to help with imaging scans. PET/CT uses a scanner to make detailed, computerized pictures of areas inside the body. PET/CT with Fluorine F 18 fluorthanatrace may allow more tumor cells to be found in patients with ovarian, fallopian tube, or primary peritoneal cancer.

Подробное описание

PRIMARY OBJECTIVES:

\- Evaluate fluorine F 18 fluorthanatrace (\[18F\]Fluorthanatrace) positron emission tomography/computed tomography (PET/CT) as an imaging biomarker of poly \[ADP-ribose\] polymerase (PARP)-1 activity in 3 cohorts of cancer patients: 1) ovarian, fallopian tube, primary peritoneal 2) breast cancer, and 3) non-ovarian, non-breast solid tumor.

SECONDARY OBJECTIVES:

* Evaluate the safety of \[18F\]Fluorthanatrace. * Correlate \[18F\]Fluorthanatrace uptake measures with BRCA mutation status. * Correlate \[18F\]Fluorthanatrace uptake measures with poly \[ADP-ribose\] polymerase (PARP-1) activity in tumor tissue samples in patients who undergo biopsies. * Evaluate change in \[18F\]Fluorthanatrace uptake measures after therapy initiation with repeat imaging before and after treatment initiation. * To confirm the variability of imaging findings from repeated \[18F\]FTT PET/CT over 1 week before treatment initiation * Determine the change in \[18F\]FluorThanatrace uptake before treatment initiation and at time of clinical progression * Correlate \[18F\]FluorThanatrace uptake at time of clinical progression measures with genetic reversion mutation status

OUTLINE:

Patients receive fluorodeoxyglucose (FDG) intravenously (IV) and undergo FDG PET/CT scan over 20-30 minutes if they have not already had one per standard of care. At least 20-24 hours later, patients receive fluorine F 18 fluorthanatrace IV and undergo fluorine F 18 fluorthanatrace (\[18F\]FTT) PET/CT over 1 hour.

After completion of study treatment, patients are followed up at 24 hours.

Вмешательства

  • Процедура Computed Tomography
    Undergo FDG PET/CT
  • Процедура Computed Tomography
    Undergo \[18F\]FTT PET/CT
  • Лучевая терапия Fludeoxyglucose F-18
    Given IV
  • Лучевая терапия Fluorine F 18 Fluorthanatrace
    Given IV
  • Процедура Positron Emission Tomography
    Undergo FDG PET/CT
  • Процедура Positron Emission Tomography
    Undergo \[18F\]FTT PET/CT

Первичные конечные точки

  • Poly (ADP-ribose) polymerase inhibitor (PARP)-1 activity as assessed by fluorine F 18 fluorthanatrace positron emission tomography/computed tomography [Срок оценки: Up to 4 years]
Вторичные конечные точки (4)
  • Incidence of adverse events [Срок оценки: Up to 4 years]
  • BRCA mutation status [Срок оценки: Up to 4 years]
  • PARP-1 activity in tumor tissue samples [Срок оценки: Up to 4 years]
  • Change in fluorine F 18 fluorthanatrace uptake measures after therapy [Срок оценки: Baseline up to 4 years]

Критерии участия

Критерии включения

  • History of known or suspected solid tumor.
  • At least one lesion ≥ 1.0 cm that is seen on standard imaging (e.g. computed tomography \[CT\], magnetic resonance imaging \[MRI\], ultrasound, fludeoxyglucose \[FDG\] PET/CT).

Критерии исключения

  • Females who are pregnant or breast feeding at the time of screening will not be eligible for this study; a urine pregnancy test will be performed in women of child-bearing potential < 2 weeks prior to screening as standard of care.
  • Inability to tolerate imaging procedures in the opinion of an investigator or treating physician.
  • Any current medical condition, illness, or disorder as assessed by medical record review and/or self-reported that is considered by a physician investigator to be a condition that could compromise participant safety or successful participation in the study.

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
Лечение

Центры проведения

США · 1 центр
  • M D Anderson Cancer Center — Houston

Публикации

  • Lin LL, Wong F, Lin R, Yap T, Litton JK. Pharmacodynamic Activity of [18F]-Fluorthanatrace Poly(ADP-ribose) Polymerase Positron Emission Tomography in Patients With BRCA1/2-Mutated Breast Cancer Receiving Talazoparib. JCO Precis Oncol. 2024 Aug;8:e2400303. doi: 10.1200/PO.24.00303. PMID 39208372

Идентификаторы

NCT: NCT03604315 · 2017-0319 · NCI-2018-01137 · 2017-0319 · R01CA249329

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗