Imaging Study of [89Zr]DFO-YS5 for Detecting CD46 Positive Malignancy in Multiple Myeloma

Официальное название

Pilot PET Imaging Study of [89Zr]DFO-YS5 for Detecting CD46 Positive Malignancy in Multiple Myeloma

Обзор

This phase I trial tests the safety of \[89Zr\]DFO-YS5 positron emission tomography (PET) imaging and how well it works to detect CD46 positive cancer cells in patients with multiple myeloma. \[89Zr\]DFO-YS5 is an imaging agent called a radiopharmaceutical tracer. A radiopharmaceutical tracer uses a small amount of radioactive material that is injected into a vein to help image different areas of the body. \[89Zr\]DFO-YS5 targets a specialized protein called CD46, which is in certain multiple myeloma cancer cells, and \[89Zr\]DFO-YS5 PET scans may improve detection of multiple myeloma.

Подробное описание

PRIMARY OBJECTIVE:

I. To determine the sensitivity of metastatic lesion detection in multiple myeloma using zirconium Zr 89-DFO-YS5 (\[89Zr\]DFO-YS5 PET, as compared with fludeoxyglucose F-18 (18F-FDG) PET imaging.

SECONDARY OBJECTIVES:

I. To determine the safety of \[89Zr\]DFO-YS5. II. To determine the average organ uptake of \[89Zr\]DFO-YS5. III. To descriptively report the patterns of intra-tumoral uptake of \[89Zr\]DFO-YS5 on whole body PET, including by site of disease, uptake by tumor type, inter-tumoral and inter-patient heterogeneity, and tumor-to-background signal.

IV. To calculate the dosimetry of \[89Zr\]DFO-YS5 in patients with multiple myeloma.

EXPLORATORY OBJECTIVE:

I. To determine the association between uptake (standardized uptake value maximum \[SUVmax\]) of \[89Zr\]DFO-YS5 with 1q amplification by fluorescence in situ hybridization (FISH) on tumor biopsies (when available; FISH may be conducted as part of routine, standard-of-care).

OUTLINE: Participants are assigned to 1 of 2 cohorts based on participant preference.

COHORT A: Participants receive \[89Zr\]DFO-YS5 intravenously (IV) and undergo a single PET/CT or PET/MRI scan 5-7 days post-injection. Participants also receive fludeoxyglucose F-18 IV and undergo PET/CT or PET/MRI scan within 28 days prior to day 1.

COHORT B: Participants receive \[89Zr\]DFO-YS5 IV and undergo four PET/CT or PET/MRI scans on days 1, 2, 3-4, and 5-7 post-injection. Participants also receive fludeoxyglucose F-18 IV and undergo PET/CT or PET/MRI scan within 28 days prior to day 1.

Patients are followed up at 30 days after final scan.

Вмешательства

• Препарат Zirconium Zr 89-DFO-YS5
  Given IV
• Процедура Positron Emission Tomography / Computed Tomography (PET/CT)
  Positron emission tomography-computed tomography is a nuclear medicine technique which combines, in a single gantry, a positron emission tomography scanner and an x-ray computed tomography scanner, to acquire sequential images from both devices in the same session, which are combined into a single superposed image
• Процедура Positron Emission Tomography / Magnetic Resonance Imaging (PET/MRI)
  Positron emission tomography-magnetic resonance imaging is a hybrid imaging technology that incorporates magnetic resonance imaging soft tissue morphological imaging and positron emission tomography functional imaging.
• Другое Fludeoxyglucose F-18
  Given IV

Первичные конечные точки

• Sensitivity of metastatic lesion [Срок оценки: Up to 1 week]
• Median maximum standardized uptake value (SUVmax) [Срок оценки: Up to 1 week]
• Median Standardized Uptake Value averaged across lesions (SUVmax-avg) [Срок оценки: Up to 1 week]

Вторичные конечные точки (4)

• Proportion of participants reporting treatment-related Adverse Events [Срок оценки: Up to 35 days]
• Average organ uptake of [89Zr]DFO-YS5 [Срок оценки: Up to 1 week]
• Descriptive patterns of intra-tumoral uptake of [89Zr]DFO-YS5 [Срок оценки: Up to 1 week]
• Dosimetry measurements (Cohort B only) [Срок оценки: Up to 1 week]

Критерии участия

Критерии включения

• Participants must have histologically or cytologically confirmed multiple myeloma by International Myeloma Working Group (IMWG) diagnostic criteria
• At least one positive myelomatous lesion found on 18F-FDG PET/CT or PET/MRI. A positive lesion is defined as uptake greater than liver on FDG PET, based on the Italian myeloma criteria for PET use (IMPeTUs) criteria
• Age >= 18 years
• Total bilirubin =< 1.5 X institutional upper limit of normal (ULN)
• Aspartate aminotransferase (AST) =< 3 X ULN
• Alanine aminotransferase (ALT) =< 3 X ULN
• Creatinine clearance >= 30 mL/min, calculated using the Cockcroft-Gault equation or serum creatinine <= 1.5x the institutional upper limit of normal.
• Ability to understand a written informed consent document, and the willingness to sign it

Критерии исключения

• Any condition that, in the opinion of the principal investigator, would impair the participants' ability to comply with study procedures or interfere with the safety of the investigational regimen
• Individuals who are pregnant or breastfeeding/chestfeeding.
• \- Breast-feeding/chest-feeding should be discontinued before administration of \[89ZR\]DFO-YS5.
• Females of childbearing potential must have a negative urine or serum pregnancy test (i.e., human chorionic gonadotropin test) within 72 hours prior to administration of \[89ZR\]-DFO-YS5.
• \- If the urine pregnancy test is positive or equivocal, a confirmatory serum pregnancy test is required. In such cases, the individual must be excluded from participation if the serum pregnancy result is positive.
• \- A female is considered to be of childbearing potential (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice), unless it is documented that the individual meets 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).
• Individuals who are pregnant or breastfeeding/chestfeeding 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

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 · 1 центр

• University of California, San Francisco — San Francisco

Идентификаторы

NCT: NCT05892393 · 23925 · NCI-2023-04068 · R01CA271606

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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