NCT04708483 - Clinical Trial References

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Citation(s)

Even AJG, Reymen B, La Fontaine MD, Das M, Mottaghy FM, Belderbos JSA, De Ruysscher D, Lambin P, van Elmpt W
Clustering of multi-parametric functional imaging to identify high-risk subvolumes in non-small cell lung cancer. Radiother Oncol. 2017 Dec;125(3
Hwang SH, Yoo MR, Park CH, Jeon TJ, Kim SJ, Kim TH
Dynamic contrast-enhanced CT to assess metabolic response in patients with advanced non-small cell lung cancer and stable disease after chemotherapy or chemoradiotherapy. Eur Radiol. 2013 Jun;23(6):1573-81. doi: 10.1007/s00330-012-2755-0. Epub 2013 Jan 9.
Korn RL, Crowley JJ
Overview: progression-free survival as an endpoint in clinical trials with solid tumors. Clin Cancer Res. 2013 May 15;19(10):2607-12. doi: 10.1158/1078-0432.CCR-12-2934. Review.
Qiao PG, Zhang HT, Zhou J, Li M, Ma JL, Tian N, Xing XD, Li GJ
Early evaluation of targeted therapy effectiveness in non-small cell lung cancer by dynamic contrast-enhanced CT. Clin Transl Oncol. 2016 Jan;18(1):47-57. doi: 10.1007/s12094-015-1335-6. Epub
Strauch LS, Eriksen RØ, Sandgaard M, Kristensen TS, Nielsen MB, Lauridsen CA
Assessing Tumor Response to Treatment in Patients with Lung Cancer Using Dynamic Contrast-Enhanced CT. Diagnostics (Basel). 2016 Jul 21;6(3). pii: E28. doi: 10.3390/diagnostics6

DCE-CT of Thoracic Tumors as an Early Biomarker for Treatment Monitoring in Comparison With Morphologic Criteria

Clinical trial NCT04708483 - References