NOTA Clinical Trials

Size	Price	Qty
5mg	USD 97

Clinical Trials

Several clinical trials are currently recruiting participants to evaluate NOTA-conjugated radiopharmaceuticals for diagnostic positron-emission tomography (PET) and non-invasive cancer staging. Sponsored by hospital institutions such as Huashan Hospital and RenJi Hospital, these studies focus on solid tumors, including colorectal, non-small cell lung, bladder, and pancreatic neoplasms. Reflecting standard diagnostic imaging protocols, all of these ongoing evaluations are classified under a Not Applicable phase designation.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT06203587	Recruiting	Positron-Emission Tomography\|Colorectal Neoplasms	Huashan Hospital	2023-12-01	Not Applicable
NCT06203574	Recruiting	Positron-Emission Tomography\|Neoplasms	Huashan Hospital	2023-12-01	Not Applicable
NCT06203613	Recruiting	Positron Emission Tomography\|Pancreatic Neoplasms\|Igestive System Neoplasms	YiHui Guan\|Huashan Hospital	2023-12-01	Not Applicable
NCT06005116	Recruiting	Bladder Cancer	RenJi Hospital	2023-09-15	Not Applicable
NCT06165874	Recruiting	Non-small Cell Lung Cancer	Huashan Hospital	2023-03-12	Not Applicable

(data from https://clinicaltrials.gov, updated on 2024-05-22)

Check the NOTA product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

As a bifunctional macrocyclic chelator, NOTA stably coordinates radiometal ions such as gallium-68 within targeting biomolecules, preventing isotope dissociation and maintaining probe integrity in physiological environments. This stable radiolabeling facilitates targeted accumulation at tumor sites, enabling high-contrast diagnostic visualization via positron-emission tomography in clinical conditions such as colorectal, non-small cell lung, bladder, and pancreatic neoplasms.

Appendix RUO and cGMP Quality Standards

Quality Dimension	RUO (Research Use Only)	cGMP (Current Good Manufacturing Practice)
Clinical Applicability	Prohibited in human clinical trials or medical diagnostics.	Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status	Non-regulated grade; exempt from drug manufacturing laws.	Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment	Unclassified analytical or research laboratories.	Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control	Basic purity and activity testing.	Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation	Basic equipment calibration; no process validation required.	Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance	Vendor self-declared without required formal QMS.	Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact	High risk of IND rejection if used as a critical raw material.	Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).