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99mTc-Pyrophosphate · 1 trial · 1 indication
Whole body effective radiation dose assessed from analysis of organ-specific radioactivity uptake in planar and SPECT images.
| Arm | Type | Description |
|---|---|---|
| Estimation of dosimetry for 99mTc-p5+14 and Biodistribution Of 99mtc-p5+14 In Healthy Subjects | EXPERIMENTAL | For dosimetry, healthy subjects (n=3) and patients with a confirmed diagnosis of AL (n=1) or ATTR amyloidosis (n=1) will be administered a single IV dose of up to 1 mg of 99mTc-p5+14 (\~20 mCi) by slow push (\~1 mL/5 sec.). Subjects will then undergo serial planar scintigraphic imaging at \~30 minutes, \~1 hour, \~2 hours, \~4 hours, \~6 hours, and \~24 hours post-injection. At the 4-hour time point, the subject will also undergo a single SPECT/CT scan to provide additional data for estimating dosimetry. Before injection of the radiotracer and at each imaging session, \~2 -3 mL of blood will be acquired to determine the whole blood radioactivity. An echo examination will also be performed. For physiological biodistribution, healthy volunteers (n=5) will undergo an echo examination, thereafter, they will be administered a single IV dose of 99mTc-p5+14 (20 mCi) and will undergo a planar image acquisition followed by SPECT/CT imaging at \~1 hour and \~3 hours post-injection. |
| Biodistribution in patients with systemic AL or ATTR amlyoidosis | EXPERIMENTAL | On Day 1, patients with a confirmed diagnosis of systemic AL or ATTR (with or without a positive PyP scan) will be administered a single IV dose of up to 1 mg of 99mTc-p5+14 (\~20 mCi) by slow push (\~1 mL/5 sec.). At \~1 hour and \~3 hours post-injection, patients will undergo whole body planar imaging followed by abdominothoracic SPECT/CT imaging. Vital signs (blood pressure, respiration rate, temperature, and pulse) will be acquired before injection of the 99mTc-p5+14, and at \~3 hours post injection. ECG measurements will be made within 1 hour prior to, and within 15 minutes after, injection. On Day 3, patient will undergo a trans thoracic echo examination. On Day 4, patients will undergo Technescan™ 99mTc-PYP (20 mCi) planar and SPECT/CT imaging at \~1 hour and \~3 hours post-injection. Vital signs (blood pressure, respiration rate, temperature, and pulse) will be acquired before injection of the 99mTc-PYP, and at \~3 hours post injection. ECG measurements will be made as on Day 1. |
| Name | Type | Description |
|---|---|---|
| 99mTc-p5+14 is an amyloid reactive peptide labeled with technetium-99m. | DRUG | Peptide p5+14 is a pan-amyloid reactive, synthetic 45 L-amino acid polypeptide with a net +12 positive charge that can bind two major components of all extracellular amyloid deposits: (i) hypersulfated heparan sulfate glycosaminoglycans (proteoglycans) and (ii) amyloid fibrils. The polypeptide, labeled with iodine-124, has been shown (study AMY1001) to bind amyloid in all organs including the heart. This study will evaluate a Tc-99m-labeled version of the peptide for gamma imaging. |
| 99mTc-Pyrophosphate | DRUG | 99mTc-PYP is an FDA-approved, commercially available bone-seeking radiotracer used routinely in nuclear medicine. 99mTC-PYP imaging is used clinically for the diagnosis of cardiac ATTR amyloidosis. |
Inclusion Criteria: PART 1 1\) Understand the study procedures and agree to participate in the study by giving written informed consent.. 2\) Be male or female \>18 years of age. 3) Women of child-bearing potential (WOCBP) (those who have not been surgically sterilized, are not postmenopausal \[i...
99mTc-Pyrophosphate is an investigational small molecule being studied for use in systemic amyloidosis. It is currently in Phase 1 clinical development, with an active trial recruiting patients with AL or ATTR systemic amyloidosis. The drug is not yet approved and remains under investigation.
99mTc-Pyrophosphate is a small molecule that is being studied for imaging in systemic amyloidosis. The specific molecular target is not disclosed in the available information. Its mechanism of action is not detailed, but it is being evaluated in a Phase 1 trial for this condition.
99mTc-Pyrophosphate is being developed by Bayer AG, a company traded under the ticker BAYRY. The drug is currently in Phase 1 clinical development for systemic amyloidosis, with an active trial recruiting participants in the United States.
99mTc-Pyrophosphate is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. A Phase 1 study is currently recruiting participants with systemic amyloidosis, including healthy volunteers, to evaluate the drug.
99mTc-Pyrophosphate is being studied in a Phase 1 clinical trial with the identifier NCT05951816. The trial, titled 'A Phase 1 Study of 99mTc-p5+14 in Healthy Volunteers and Patients With AL or ATTR Systemic Amyloidosis,' is recruiting 31 participants in the United States. It is a controlled, randomized study that includes healthy volunteers.
Yes, 99mTc-Pyrophosphate is also known as 99mTc-p5+14. The Phase 1 clinical trial NCT05951816 uses the name 99mTc-p5+14 in its title, and it is being studied for systemic amyloidosis. Both names refer to the same investigational drug.