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The benefits of AIQ treatment response assessments (TRA) for clinical studies

Predict the likelihood of favorable response shortly after study initiation

AIQ can correlate early intelligence on individual-lesion response to long-term patient treatment response; this is delivered in an easy-to-understand, patient-level metric (AIQ Score).

EVALUATE NOVEL THERAPIES
FASTER

Pilot studies can use AIQ’s data to compare the effectiveness of permutations of sequence and combination therapies before committing to a more extensive study.

HOW WE IMPROVE TREATMENT RESPONSE DECISIONS

An AIQ Solutions clinical trial case study13

Change in SUVtotal, as quantified by AIQ technology, demonstrated a decrease in disease burden of 23% for the experimental arm after six months of treatment while the corresponding control group demonstrated an increase of 53%. This difference achieved a p-value of 0.071 despite a sample of only 34 patients.

Methods

Madison Vaccines Incorporated (MVI) conducted a Phase II prospective, randomized controlled trial with 97 non-metastatic castration-sensitive prostate cancer (nmCSPC) patients. The study compared outcomes for a pTVG-HP vaccine with adjuvant sargramostin (experimental arm) to outcomes for sargramostin alone (control arm). Patients were classified as non-metastatic using conventional imaging. The primary endpoint was 2-year metastasis-free survival (2YMFS). AIQ technology was used to study pharmacodynamic effects in a subset of 34 patients, who had multiple PET/CT scans.

Results

The initial results for the 97 patient study showed no difference in 2YMFS between the experimental and control arms (41.8% and 42.3%, respectively, p=0.97). The AIQ TRA, however, demonstrated positive pharmacodynamic effects for the vaccine. After six months of treatment, total disease burden, measured as SUVTOTAL, decreased by 23% in the experimental group while it increased by 50% in the control arm (p=0.071). Further, while all patients were classified as non-metastatic by conventional imaging, the AIQ TRA detected lesions at the beginning of treatment in 30 of 34 patients.

Conclusion

The combination of 97 patients and 24-month monitoring failed to meet the primary endpoint of MFS. 34 patients and 6-month monitoring were sufficient to demonstrate benefit for the vaccine using the AIQ TRA. The intelligence provided by AIQ helped MVI decide to continue development of pTVG-HP asset.
Read more about how AIQ actionable intelligence on pharmacodynamic effects improves clinical studies

AIQ works within your clinical study workflow

AIQ's workflow is simple and easy to implement for single or multi-site studies. We also partner with Contract Research Organizations (CROs) to help with imaging data acquisition if needed.

What clinical questions do you have?

Learn more about how AIQ Solutions can support your early-stage clinical studies.

Per the US FDA, AIQ technology is indicated for use in the identification, quantification, and evaluation of Regions of Interest (ROIs) from digital medical images, including PET and CT. Any other applications of AIQ technology are for research purposes only.