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Идёт набор NCT05562791

A Study of 68Gallium PSMA-PET/CT Scans in People With Bladder Cancer or Skin Cancer

Фаза I С лечением Bladder Cancer

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: [68Ga]PSMA, PET/CT imaging.
Кому может быть актуально
Состояния в реестре: Bladder Cancer. 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
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

Pilot Study of 68Gallium PSMA-PET/CT in Patients With Metastatic Urothelial Carcinoma or Melanoma

Обзор

The purpose of this study is to see whether 68Gallium PSMA-PET/CT scans are an effective way to detect sites of cancer in people with metastatic bladder cancer or skin cancer. The study researchers want to learn if a 68Gallium PSMA PET/CT scan will work better, the same, or not as well as the PET/CT scans doctors usually use for imaging bladder cancer or skin cancer (FDG-PET/CT scan).

Вмешательства

  • Препарат [68Ga]PSMA
    68Gallium PSMA-PET/CT imaging within 10 days after standard of care FDG-PET/CT.
  • Диагностический тест PET/CT imaging
    68Gallium PSMA-PET/CT imaging within 10 days after standard of care FDG-PET/CT.

Первичные конечные точки

  • Define the proportion of patients with 1 or more lesions detectable by 68Gallium PSMA-PET/CT for Urothelial Carcinoma [Срок оценки: 1 year]
  • Define the proportion of patients with 1 or more lesions detectable by 68Gallium PSMA-PET/CT for Melanoma [Срок оценки: 1 year]

Критерии участия

Inclusion Criteria for Urothelial Carcinoma Cohort:

  • Patients with histologically confirmed metastatic urothelial carcinoma with extrapelvic nodal and/or visceral sites of disease (including lung, liver, bone, or soft tissue)
  • At least 1 lesion assessable by FDG PET/CT according to RECIST and PERCIST guidelines where applicable, that are determined suspicious for metastasis by an MSKCC attending radiologist or nuclear medicine physician.
  • Karnofsky performance status ≥50% (or ECOG/WHO ≤2)
  • Participant is ≥18 years of age
  • Patient must be able to understand and is willing to sign a written informed consent document

Inclusion Criteria for Melanoma Cohort:

  • Patients with histologically confirmed metastatic melanoma
  • At least 1 metastatic lesion assessable by CT or FDG PET/CT according to RECIST that is determined to be suspicious for metastasis by an MSKCC attending radiologist or nuclear medicine physician
  • ECOG <= 2
  • Participant is >= 18 years of age
  • Patient must be able to understand and is willing to sign a written informed consent document

Exclusion Criteria for Urothelial Carcinoma Cohort:

  • Patients with pelvic node-only metastatic disease. If the patient has lymph node only disease, at least one PET-assessable node must be located outside of the pelvis
  • Patients with bone only disease
  • Unable to lie flat, still, or to tolerate a PET scan
  • Patient undergoing active treatment for non-urothelial malignancy, other than skin basal cell or cutaneous superficial squamous cell carcinoma that has not metastasized.
  • Patients on a therapeutic clinical trial where PSMA imaging would interfere with the conduct of the trial
  • Patients undergoing active surveillance with a known history of non-urothelial malignancies
  • Women who are pregnant. All women of childbearing potential must have a documented negative pregnancy test.

Exclusion Criteria for Melanoma Cohort:

  • Unable to lie flat, still, or tolerate PET scan.
  • Patient is on another therapeutic trial where PSMA imaging would interfere with the conduct of the trial.
  • Women who are pregnant. All women of childbearing potential must have a documented negative pregnancy test.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Нерандомизированное
Модель
Одна группа
Маскирование
Открытое
Основная цель
Диагностика

Центры проведения

США · 7 центров
  • Memorial Sloan Kettering Basking Ridge (Consent Only) — Basking Ridge
  • Memorial Sloan Kettering Monmouth (All Protocol Activities) — Middletown
  • Memorial Sloan Kettering Bergen (All Protocol Activities) — Montvale
  • Memorial Sloan Kettering Suffolk - Commack (All Protocol Activities) — Commack
  • Memorial Sloan Kettering West Harrison (All Protocol Activities) — Harrison
  • Memorial Sloan Kettering Cancer Center (All Protocol Activities) — New York
  • Memorial Sloan Kettering Nassau (All Protocol Activities) — Uniondale

Идентификаторы

NCT: NCT05562791 · 22-157

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗