Listen mate I'l try and help you
The trial has 3 endpoints:-
1) Tolerability ie no adverse events/t toxicity
2) Improves the performance of traditional MRI
3) Is detectable in the nodes with magnetic relaxometry sensor.
The sample size has to be between 10 and 15 cohorts to be statistically valid.
Statistical validity and reliability need to be confirmed. You need to read up on this plus p values to understand this.
All 3 endpoints have been achieved. All this information is already out there and I draw your attention to Imagion Biosystems Homepage for this information and in particular the article :-Imagion presents MagSense® interim study results at breast cancer meeting
An expert from the article is highlighted for you as below:-DECEMBER 8, 2022Previously the Company has reported that the MagSense® HER2 imaging agent has been well tolerated and that there have been no safety issues related to the agent identified. Here the Company reports for the first time the initial findings of the exploratory endpoints related to cancer detection. Analysis of the first cohort of six patients suggests that the molecular signature of the MagSense imaging agent, when used with conventional MRI could help discriminate potentially cancerous nodes from normal nodes. The work was presented by Dr. Yalia Jayalakshmi, Chief Development Officer at Imagion Biosystems, and co-authored by study principal investigators. Together, the authors conclude that when combined with standard morphological assessments, the imaging agent “has the potential to improve radiological evaluation thereby improving the standard of care clinical assessments.” The Company notes that enrolment for the second cohort is ongoing with results consistent with those reported at the meeting and that further studies will be needed to broaden the study population to fully characterize the diagnostic performance of the imaging agent.
Several important findings have emerged from the results to date:
- changes in MR contrast created by the specific binding of the MagSense imaging agent to tumour cells in the nodes aids in resolving nodal status;
- the imaging agent is detectable by magnetic relaxometry, however, more subject samples are needed due to the limited amount of accessible dissected nodal tissue to date; and
- there have been no safety, toxicity or adverse events reported related to the imaging agent
“We are very excited to be reporting our first clinical data at this important breast cancer meeting”, said Bob Proulx, CEO. “The results presented at the meeting are focused on the study protocol’s first cohort of six patients only, and though the number of patients might seem small, the implications for the Company are large as they provide the first proof-of-principle of our targeted nanoparticle technology in the clinical setting. Evidence in real patients that our nanoparticle technology could improve upon conventional medical imaging methods is a major milestone for the Company. We are very pleased to be sharing these results with our shareholders and we look forward to providing additional updates as we make further progress.”
End of Excert
The link is .https://imagionbiosystems.com/news/imagion-presents-magsense-interim-study-results-at-breast-cancer-meeting/
