64Cu-LLP2A for Imaging Hematologic Malignancies

Официальное название

Early Phase I Evaluation of 64Cu-LLP2A for Imaging Hematologic Malignancies Part B

Обзор

This phase of the protocol (protocol part B), seeks to evaluate the new formulation in healthy normal volunteers to confirm the new formulation provides comparable human dosimetry to which was seen and published in protocol part A. Additionally, the new formulation will be studied utilizing an expanded patient population to include patients with confirmed diagnosis of multiple myeloma (MM), low-grade lymphoma, or MM and lymphoma patients who are status post bone marrow transplant (BMT) with negative imaging and suspected recurrence.

Вмешательства

• Препарат 64Cu-LLP2A
  64Cu-LLP2A, will be manufactured following batch production record at the cyclotron GMP facility (Washington University School of Medicine GMP radiochemistry/cyclotron facility)
• Устройство PET/CT
  The results of 64Cu-LLP2A-PET/CT will not be provided to the patient or the treating oncologist/surgeon unless, in the judgment of the principal investigator, the images demonstrate an unsuspected abnormality that may warrant further evaluation.

Первичные конечные точки

• Organ dosimetry of participants [Срок оценки: Through completion of PET/CT scans (estimated to be up to 2 days)]
• Safety and tolerability of new formulation of 64Cu-LLP2A as measured by number of participants with adverse events [Срок оценки: From beginning of administration of 64Cu-LLPA2A through last phone call assessment (up to 7 days total)]

Вторичные конечные точки (3)

• Evaluate the quality of PET images with new formulation 64Cu-LLP2A as measured by overall quality of PET images [Срок оценки: Through completion of PET/CT scans (estimated to be up to 2 days)]
• Evaluate the quality of PET images with new formulation 64Cu-LLP2A as measured by bone marrow uptake [Срок оценки: Through completion of PET/CT scans (estimated to be up to 2 days)]
• Evaluate the quality of PET images with new formulation 64Cu-LLP2A as measured by tumor/background ratio [Срок оценки: Through completion of PET/CT scans (estimated to be up to 2 days)]

Критерии участия

Inclusion Criteria Healthy Volunteer:

• Adult 18 years of age or older
• Able to give informed consent.
• Able to comprehend and willing to follow instructions for study procedures as called for by the protocol
• Capable of lying still and supine within the PET/CT scanner for up to 75 minutes.
• No illicit drug use or other inhaled drug use (including pharmacologic agents and illicit drugs) within the past year per self-reporting mechanisms.
• No history of claustrophobia or other condition that has previously or would interfere with completion of protocol specified imaging sessions.
• Not currently pregnant or nursing: Subject must be surgically sterile (has had a documented bilateral oophorectomy and/or documented hysterectomy), post-menopausal (cessation of menses for more than 1 year), non-lactating, or of childbearing potential for whom a urine pregnancy test (with the test performed within the 24 hour period immediately prior to administration of 64Cu-LLP2A) is negative.

Inclusion Criteria Hematological Malignancy:

• Clinical or pathologically defined MM or lymphoma including both newly diagnosed, relapsed or refractory disease:

• Multiple Myeloma defined in accordance with the International Myeloma Working Group criteria
• Low-grade lymphoma, including the following subtypes: follicular lymphoma, marginal zone lymphoma, lymphoplasmacytic lymphoma, small lymphocytic lymphoma/chronic lymphocytic leukemia
• Adult 18 years of age or older and able to provide informed consent
• Capable of lying still and supine within the PET/CT scanner for up to 75 minutes.
• No history of claustrophobia or other condition that has previously or would interfere with completion of protocol specified imaging sessions
• Not currently pregnant or nursing: Subject must be surgically sterile (has had a documented bilateral oophorectomy and/or documented hysterectomy), post-menopausal (cessation of menses for more than 1 year), non-lactating, or of childbearing potential for whom a urine pregnancy test (with the test performed within the 24 hour period immediately prior to administration of 64Cu-LLP2A) is negative
• Patients participating in imaging or therapeutic trials with investigational agents are eligible to participate

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Диагностика

Центры проведения

США · 1 центр

• Washington University School of Medicine — St Louis

Идентификаторы

NCT: NCT06636175 · 202505198 · R42CA257797

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗