Early Phase I Evaluation of 64Cu-LLP2A for Imaging Hematologic Malignancies Part B
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- Organ dosimetry of participants
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- 未提供
研究组 & 干预措施
Pilot/Cohort 1B: Dosimetry 64Cu-LLP2A
- Will be asked to undergo 64Cu-LLP2A-PET/CT imaging at up to three separate time points for purposes of calculating human dosimetry. Imaging time points will be dependent upon day of the week injection occurs:
- Tuesday or Thursday injection: 0-60 minute multiple quick body scans + 120-180 min post injection body scan
- Wednesday or Friday injection: 0-60 minute multiple quick body scans + 180-240 min post injection body scan
- ALL PATIENTS: 15-28 hours post injection body scan on Wednesday (for Tuesday injection), Thursday (for Wednesday injection), Friday (for Thursday injection) or Saturday (for Friday injection)
干预措施: PET/CT (Device)
Cohort 2B: Quantitative 64Cu-LLP2A
- Will be asked to undergo dynamic PET/CT imaging centered over a known target lesion (as determined by other radiological imaging studies) beginning with 64Cu-LLP2A-PET/CT and continuing for a total of 60 minutes. An additional vertex to upper thigh body scan will be obtained between 60- and 180-minutes post injection or at the optimal imaging time point that was derived from cohort 1B.
干预措施: PET/CT (Device)
Pilot/Cohort 1B: Dosimetry 64Cu-LLP2A
- Will be asked to undergo 64Cu-LLP2A-PET/CT imaging at up to three separate time points for purposes of calculating human dosimetry. Imaging time points will be dependent upon day of the week injection occurs:
- Tuesday or Thursday injection: 0-60 minute multiple quick body scans + 120-180 min post injection body scan
- Wednesday or Friday injection: 0-60 minute multiple quick body scans + 180-240 min post injection body scan
- ALL PATIENTS: 15-28 hours post injection body scan on Wednesday (for Tuesday injection), Thursday (for Wednesday injection), Friday (for Thursday injection) or Saturday (for Friday injection)
干预措施: 64Cu-LLP2A (Drug)
Cohort 2B: Quantitative 64Cu-LLP2A
- Will be asked to undergo dynamic PET/CT imaging centered over a known target lesion (as determined by other radiological imaging studies) beginning with 64Cu-LLP2A-PET/CT and continuing for a total of 60 minutes. An additional vertex to upper thigh body scan will be obtained between 60- and 180-minutes post injection or at the optimal imaging time point that was derived from cohort 1B.
干预措施: 64Cu-LLP2A (Drug)
结局指标
主要结局
Organ dosimetry of participants
时间窗: Through completion of PET/CT scans (estimated to be up to 2 days)
Confirm organ dosimetry in healthy subjects and in patients with various hematological malignancies is consistent with prior formulation of 64Cu-LLP2A (all of Cohort 1 + up to 10 cohort 2 subjects). Average organ activity concentration will be measured, and decay corrected by utilizing regions of interest (ROIs) drawn around all organ visible on 64Cu-LLP2A images. Activity organ residence times will be calculated by numerical or analytical integration of the time-activity curves. Uptake/clearance functional fits of mono- or bi-exponential functions will be performed and analytical integration, accounted for physical decay, will be performed. The calculated residence times will be used with the program OLINDA/EXM for 64Cu and using the adult human (female and male) model to calculate the individual organ radiation dose, the whole-body dose and the effective dose.
Safety and tolerability of new formulation of 64Cu-LLP2A as measured by number of participants with adverse events
时间窗: From beginning of administration of 64Cu-LLPA2A through last phone call assessment (up to 7 days total)
Follow-up telephone call or in person visit to assess for self-reported adverse events associated with injection of 64Cu-LLP2A or PET/CT imaging. Additional chart review can be performed as needed.
次要结局
- Evaluate the quality of PET images with new formulation 64Cu-LLP2A as measured by overall quality of PET images(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(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(Through completion of PET/CT scans (estimated to be up to 2 days))