Al18F-NOTA-octreotide PET Imaging of the Somatostatin Receptor in Neuroendocrine Tumors
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|ClinicalTrials.gov Identifier: NCT03883776|
Recruitment Status : Recruiting
First Posted : March 21, 2019
Last Update Posted : April 16, 2019
|Condition or disease||Intervention/treatment||Phase|
|Neuroendocrine Tumors||Drug: Al18F-NOTA-octreotide Device: PET/CT Other: Venous blood samples||Phase 1|
In the first part of the study, six healthy volunteers will undergo several sequential whole-body PET/CT scans starting from the moment of tracer injection up to six hours post injection for an initial safety assessment and dosimetry study of Al18F-NOTA-octreotide in humans.
In the second part of the study, six neuroendocrine tumor patients, with at least five positive lesions on routine clinical 68Ga-DOTA-peptide PET, will undergo a dynamic PET scan for the first 45 minutes, followed by three single static whole-body PET/CTs up to three hours post injection for an initial efficacy assessment (evaluation of the lesion detection rate) and pharmacokinetics study of Al18F-NOTA-octreotide in humans. Furthermore a first comparison with 68Ga-DOTA peptide PET will be performed.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||12 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Al18F-NOTA-octreotide PET Imaging of the Somatostatin Receptor in Neuroendocrine Tumors: a First-in-human PET/CT Study|
|Actual Study Start Date :||April 11, 2019|
|Estimated Primary Completion Date :||October 2019|
|Estimated Study Completion Date :||December 2019|
Experimental: healthy volunteers and NET patients
In the first part of the study, 6 healthy volunteers will receive a single intravenous single injection of Al18F-NOTA-octreotide, followed by whole-body PET/CT scans at various time points for an initial safety assessment and dosimetry study.
In the second part of the study, a single dose of Al18F-NOTA-octreotide will be intravenously injected in 6 patients with neuroendocrine tumors. Patients will first undergo a dynamic PET scan, followed by whole-body PET/CT scans at various time points for a pharmacokinetics study and initial efficacy assessment.
One intravenous injection of 4 MBq/kg
Part 1: Healthy volunteers will undergo consecutive whole-body PET scans, including one low-dose CT, for the first 90 minutes. At 150 ± 15 min and 300 ± 30 min post injection two additional static whole-body PET/CT scans will be acquired.
Part 2: Neuroendocrine tumor patients will undergo a dynamic PET scan for the first 45 minutes, followed by 3 static whole-body PET/CTs at 60 ± 10 min, 120 ± 30 min and 180 ± 30 min post injection.
Other: Venous blood samples
Blood samples will be obtained for laboratory safety evaluation for initial screening and safety evaluation after injection. Furthermore, venous blood samples will be obtained for metabolite analysis and activity measurements (only for patients) at various time points post injection (5 ± 2 min, 10 ± 5 min, 20 ± 10 min, 40 ± 20 min, 60 ± 30 min, 120 ± 60 min).
- Potential of Al18F-NOTA-octreotide as somatostatin receptor PET imaging tracer in patients with neuroendocrine tumors [ Time Frame: 1 year ]The primary endpoint will be met if in 4 out of 6 patients, at least two tumor lesions per patient are visualized in case of 5 to 10 known positive lesions on the 68Ga-DOTA-peptide PET, or at least 25% of the known tumor lesions per patient are visualized in case of more than 10 known positive tumor lesions on the 68Ga-DOTA-peptide PET. The study will be partially positive if in at least one patient at least 80% of the known positive lesions on the 68Ga-DOTA-peptide PET is visualized.
- Dosimetry of Al18F-NOTA-octreotide [ Time Frame: 1 year ]Dosimetry will be assessed by means of the sequential whole-body PET/CT scans performed in healthy volunteers. Absorbed dose per unit of injected activity (mGy/MBq) at the organ and whole-body level will be calculated.
- Normal-organ and tumor uptake of Al18F-NOTA-octreotide as a function of time [ Time Frame: 1 year ]Patients will undergo dynamic PET scanning followed by three static whole-body PET/CT scans at different time points post injection. Uptake as a function of time (pharmacokinetics) will be studied using the software package PMOD (PMOD technologies LLC, Zürich, Switzerland). Volumes of interest (VOIs) will be delineated in relevant normal organs and tumor lesions on all PET images and standardized uptake values (SUV) in all these VOIs will be measured to compute normal-organ and tumor uptake as a function of time.
- Identify the ideal time point for imaging after Al18F-NOTA-octreotide injection [ Time Frame: 1 year ]Tumor-to-background ratios as a function of time will be measured. The time point resulting in optimal tumor-to-background ratios, taking into account a realistic implementation in clinical practice, will be defined as the ideal time point for imaging.
- Safety analysis of Al18F-NOTA-octreotide administration: Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 [ Time Frame: 1 year ]The impact of Al18F-NOTA-octreotide administration on clinical symptoms and signs and biochemistry values will be evaluated. Baseline values will be recorded and patients will be assessed clinically and with serial biochemical analysis. Adverse events will be scored according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
- Preliminary assessment of lesion targeting by Al18F-NOTA-octreotide as compared to 68Ga-DOTATATE [ Time Frame: 1 year ]A lesion-by-lesion analysis (visual and semi-quantitative) will be performed to compare the number of detected lesions using both tracers.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03883776
|Contact: Christophe Deroose, MD, PhD||+32 16 email@example.com|
|Universitaire Ziekenhuizen Leuven||Recruiting|
|Leuven, Belgium, 3000|
|Contact: Christophe Deroose, MD, PhD|
|Principal Investigator:||Christophe Deroose, MD, PhD||Universitaire Ziekenhuizen Leuven|