An Early Phase 1 interventional study of 68Ga-NOTA-3P-TATE-RGD in Lung Cancer and Neuroendocrine Neoplasm, sponsored by Peking Union Medical College Hospital. Status unknown at 1 site in China. Open to participants aged 18 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-04-07.
Sponsored by Peking Union Medical College Hospital · Early Phase 1, Interventional, and Diagnostic
This is an open-label positron emission tomography/computed tomography (PET/CT) study to investigate the diagnostic performance and evaluate the efficacy of 68Ga-NOTA-3PTATE-RGD in lung cancer patients and neuroendocrine neoplam patients. A single dose of 111-185 Mega-Becquerel (MBq) 68Ga-NOTA-3P-TATE-RGD will be injected intravenously. Visual and semiquantitative method will be used to assess the PET/CT images.
The number of somatostatin receptors may be greatly up-regulated in the cells of a variety of tumor including carcinoids, gastrinomas, paragangliomas, small cell lung cancer and non-small cell lung cancer. Octreotide is an eight amino acid cyclic peptide that preserves a four amino acid motif (Phe-Trp-Lys-Thr) that is critical for the biological activity of somatostatin (SSTR). On the other hand, the RGD moiety binds with integrin αvβ3, also plays an important role in the regulation of tumor growth, angiogenesis, local invasiveness, and metastatic potential in human tumor. To target both receptors, a heterodimeric peptide TATE-RGD was synthesized from TATE and RGD through a glutamate linker and then labeled with 68Ga. An open-label whole-body PET/ CT study was designed to investigate the safety and dosimetry of 68Ga-NOTA-3PTATE-RGD and diagnostic performance of 68Ga-NOTA-3PTATE-RGD PET/CT in evaluation of lung cancer and neuroendocrine neoplams.
7,333 studies on the registry are indexed under Lung Neoplasms; 1,554 are open to participants now.
This study's planned enrollment of 100 is above the median of 60 across 5,345 interventional studies indexed under Lung Neoplasms.
Browse Lung Neoplasms studies →Peking Union Medical College Hospital is the lead sponsor of 1,148 studies on the registry; 474 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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The patients were injected with 111-185 MBq of 68Ga-NOTA-3P-TATE-RGD in one dose intravenously and underwent PET/CT scan 45-60 min later.
Drug: 68Ga-NOTA-3P-TATE-RGD
68Ga-NOTA-3P-TATE-RGD were injected into the patients before the PET/CT scans
Standardized uptake value of 68Ga-NOTA-3PTATE-RGD in lung cancer and Neuroendocrine Neoplasm
The semiquantitative analysis will be performed by the same person for all the cases, and the standardized uptake value (SUV) of the tracer in breast cancer will be measured.
Time frame: 1 year
Ran from Jun 2016 to primary completion in Dec 2020, 54 months.
Of 217 non-industry phase 1 interventional studies under Lung Neoplasms, half reached primary completion within 55 months of starting (the median), counting those still running; a quarter within 37 and three quarters within 79. This study's 54 months is close to that.
Counting every sponsor, half of 395 studies reached it within 47 months; a quarter within 31 and three quarters within 68.
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This study is status unknown, as verified in Mar 2022. You cannot join it, but the record below documents what was studied.
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Peking Union Medical College Hospital →