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Circulating Transcript Analysis (NETest) in GEP-NETs Treated With Somatostatin Analogs Defines Therapy
Jarosław B Ćwikła1, Lisa Bodei1, Agnieszka Kolasinska-Ćwikła1
1Department of Radiology, Faculty of Medical Sciences (J.Ć.), University of Warmia and Mazury, Olsztyn 10-558, Poland; Division of Nuclear Medicine (L.B.), European Institute of Oncology, Milan 20141, Italy; Department of Oncology (A.K.-Ć.), Maria Skłodowska-Curie Memorial Cancer Center, Institute of Oncology, Warsaw 44-101, Poland; Department of Radiology (A.S.), Hospital Ministry of Internal Affairs, Warsaw 02-507, Poland; Keewaydin Consulting, Inc. (I.M.M.), Woodbridge, Connecticut 06525; and Wren Laboratories (M.K.), Branford, Connecticut 06405.
Context:
Early and precise delineation of therapeutic responses are key issues in neuroendocrine neoplasm/tumor management. Imaging is currently used but exhibits limitations in sensitivity and specificity. The utility of biomarkers is unclear. objective, setting, and design: This prospective cohort study (11 mo) sought to determine whether measurements of circulating neuroendocrine tumor transcripts (NETest) predict responses to somatostatin analogs (SSAs).
Patients:
The test set consisted of 35 SSA-treated gastroenteropancreatic-NETs (RECISTevaluated). The prospective set consisted of 28 SSA-treated Grade 1-Grade 2 GEP-NETs.
Intervention(S):
Whole blood for transcript analysis (NETest) and plasma for Chromogranin A (CgA) (baseline), were collected every 4 weeks (prior to SSA injection). Morphologic (multidetector computed tomography/MRI) and functional imaging ((99m)Tc-[HYNIC, Tyr(3)]-Octreotide) was undertaken at entry and 6-month intervals until progression (RECIST 1.0).
Main Outcome Measure(S):
Treatment response.
Results:
Test set: NETest (≥80%; scale, 0-100%) differentiated stable (SD) and progressive (PD) disease (P < .0001). Prospective set: 28 patients (26/28 SD) undergoing standard SSA. Grading: 12 G1, 16 G2. SSA Response: progression-free survival: 315 days: 14 (50%) SD, 14 (50%) PD. NETest: Twenty had elevated (≥80%) values; 14 developed PD; six, SD. CgA: Twelve of 28 exhibited elevated baseline values and/or subsequent >25% increase; eight developed PD; four, SD. NETest (P = .002) and grade (P = .054) were the only factors associated with treatment response. Multiple regression analysis established that the NETest could predict disease progression (P = .0002). NETest changes occurred significantly earlier (146 d prior to progression vs 56 d CgA; P < .0001; χ(2) = 19) and in more patients (100 vs 57%; P < .02).
Conclusions:
NETest values (80-100%) were more accurate and occurred at a significantly earlier time point than CgA and predicted SSA treatment response.
Insights
Neuroendocrine tumor transcripts (NETest) accurately predict treatment response to somatostatin analogs (SSAs) earlier than Chromogranin A. This blood test aids in managing neuroendocrine neoplasms.
Area of Science:
- Oncology
- Molecular Diagnostics
- Biomarker Research
Background:
- Accurate assessment of therapeutic response is critical for managing neuroendocrine neoplasms (NENs).
- Current imaging methods for NENs have limitations in sensitivity and specificity.
- The clinical utility of biomarkers for predicting treatment response in NENs remains unclear.
Purpose of the Study:
- To prospectively evaluate circulating neuroendocrine tumor transcripts (NETest) for predicting treatment response to somatostatin analogs (SSAs).
- To compare the predictive accuracy and timing of NETest with Chromogranin A (CgA) and imaging.
Main Methods:
- A prospective cohort study involving 28 patients with Grade 1-2 gastroenteropancreatic neuroendocrine tumors (GEP-NETs) treated with SSAs.
- Collected whole blood for NETest and plasma for CgA every 4 weeks.
- Utilized multidetector computed tomography/MRI and functional imaging at baseline and 6-month intervals.
Main Results:
- NETest (≥80%) significantly differentiated stable disease from progressive disease in a test set (P < .0001).
- In the prospective set, NETest predicted disease progression (P = .0002) and was the only factor associated with treatment response besides tumor grade.
- NETest changes preceded disease progression significantly earlier (146 days prior) and in more patients (100%) compared to CgA (56 days prior; 57%).
Conclusions:
- NETest measurements (80-100%) are more accurate than CgA in predicting SSA treatment response in GEP-NETs.
- NETest provides an earlier indication of treatment response or progression compared to CgA.
- NETest represents a valuable non-invasive biomarker for monitoring therapeutic efficacy in neuroendocrine tumor management.
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