Imaging Study of [89Zr]DFO-YS5 for Cancer Detection

Официальное название

A Pilot PET Imaging Study of [89Zr]DFO-YS5 for Detection of Cancer in Patients With Various Malignancies

Обзор

This is a single-center, pilot, PET-imaging study of the novel radiotracer 89Zirconium-89 DFO conjugated to the YS5 monoclonal antibody (\[89Zr\]DFO-YS5) in participants with nerve sheath tumor, bladder cancer, or advanced solid tumor neoplasms.

Подробное описание

PRIMARY OBJECTIVE:

I. To descriptively report patterns of \[89Zr\]DFO-YS5 uptake on whole-body PET.

SECONDARY OBJECTIVE:

II. To determine the safety of \[89Zr\]DFO-YS5.

OUTLINE:

Participants will be administered a single dose of \[89Zr\]DFO-YS5 followed by whole-body positron emission tomography (PET) imaging at a single time point. All participants will be followed for adverse events for approximately Participants in the main study will be followed for adverse events for approximately 1 month after \[89Zr\]DFO-YS5 radiotracer administration.

Вмешательства

• Препарат [89Zr]DFO-YS5
  Given intravenously (IV)
• Процедура Positron Emission Tomography (PET)-Magnetic resonance imaging (MRI)
  Participants may receive a whole-body PET-MRI or a whole body PET-CT
• Процедура Positron Emission Tomography (PET)-Computerized tomography (CT)
  Participants may receive a whole-body PET-CT or a whole-body PET-MRI

Первичные конечные точки

• Mean maximum standard uptake value (SUVmax-avg) on Positron Emission Tomography (PET) scan [Срок оценки: Up to 8 days]
• Median intra-tumoral SUVmax [Срок оценки: Up to 8 days]
• Tumor-to-background signal (Ratio) [Срок оценки: Up to 8 days]

Вторичные конечные точки (1)

• Proportion of participants with reported treatment-emergent adverse events [Срок оценки: Up to 8 days]

Критерии участия

Критерии включения

• Histological or cytological confirmation of malignant peripheral nerve sheath tumor, bladder cancer, or solid tumor neoplasm.
• At least one soft tissue lesion measurable at 1 cm or greater in short axis measurement on cross sectional imaging such as Computerized tomography (CT), magnetic resonance imaging (MRI), or Positron Emission Tomography (PET)/CT (scan imaging as documented in the medical record). Exception: For participants with localized bladder cancer (pre-cystectomy), lesions smaller than 1 centimeter (cm) are permitted, provided there is cystoscopic confirmation of a bladder mass.
• Clinically able to undergo PET-CT imaging or PET-MRI.
• Age ≥ 18 years.
• Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2 or Karnofsky ≥ 50% (see Appendix 1).
• Adequate organ function as defined below:

• Total bilirubin: ≤ 1.5 x institutional upper limit of normal (ULN) (unless elevated due to Gilbert's syndrome and direct bilirubin is within normal limits).
• Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase (SGOT)): ≤ 3 x ULN.
• Alanine aminotransferase (ALT) (serum glutamic-pyruvic transaminase (SGPT)): ≤ 3 x ULN.
• Estimated creatinine clearance: ≥ 60 mL/min, calculated using the Cockcroft-Gault equation.
• Females of reproductive potential (defined below) must be willing to undergo a urine or serum pregnancy test (i.e., human chorionic gonadotropin test) within 72 hours before administration of \[89Zr\]DFO-YS5. A female is considered to NOT be of reproductive potential (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice), if they meet either of the following two criteria: (1) has reached a postmenopausal state (≥ 12 continuous months of amenorrhea with no identified cause other than menopause); or (2) has undergone surgical sterilization (i.e., hysterectomy and/or bilateral oophorectomy for removal of uterus and/or ovaries). The result of the urine or serum pregnancy test must be negative in order to initiate the \[89Zr\]DFO-YS5 administration. If a urine pregnancy test is positive or equivocal, a confirmatory a serum pregnancy test is required. The individual must be excluded from participation if the serum pregnancy result is positive. Pregnant individuals are excluded from this study because there is an unknown but potential risk for adverse effects in the unborn child secondary to treatment of the study participant with \[89Zr\]DFO-YS5.
• Individuals with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or endpoints of this study are eligible.
• Ability to understand and the willingness to sign a written informed consent document.

Критерии исключения

• Individuals with a contraindication to PET-CT imaging (e.g., severe claustrophobia) or PET-MRI (e.g., implanted devices, metallic objects, or other implants). Participants must be able to undergo either PET-CT or PET-MRI.
• Individuals who are pregnant or breastfeeding/chest-feeding. Pregnant and breastfeeding/chest-feeding individuals are excluded because there is an unknown but potential risk for adverse effects in the unborn/nursing child secondary to treatment of the study participant with \[89Zr\]DFO-YS5. Females of childbearing potential must have a negative pregnancy test before administration of \[89Zr\]DFO-YS5, as outlined in inclusion criterion #7. Breastfeeding/chest-feeding should be discontinued before administration of \[89Zr\]DFO-YS5.
• Individuals who do not agree to follow the below contraception requirements:

Females of reproductive potential (defined below) must agree to use two forms of contraception, consisting of a barrier method (such as condoms) in combination with a secondary complementary method (such as hormonal, Intrauterine device (IUD), etc.), or strict abstinence, for the duration of study participation and for 1 month after administration of \[89Zr\]DFO-YS5. A female is considered to NOT be of reproductive potential (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice), if they meet either of the following two criteria: (1) has reached a postmenopausal state (≥ 12 continuous months of amenorrhea with no identified cause other than menopause); or (2) has undergone surgical sterilization (i.e., hysterectomy and/or bilateral oophorectomy for removal of uterus and/or ovaries).

• Hypersensitivity to \[89Zr\]DFO-YS5 or any of its excipients.
• Individuals with any condition or social circumstance that, in the opinion of the investigator, would impair the participant's ability to comply with study procedures.

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

США · 1 центр

• University of California, San Francisco — San Francisco

Идентификаторы

NCT: NCT07664397 · 26921 · NCI-2026-04664

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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