Biomarker identification of radionuclide therapy-induced radiation responses.
Recruiting
- Conditions
- Neuroendocrine tumor1002911210014713
- Registration Number
- NL-OMON51484
- Lead Sponsor
- Moleculaire genetica
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 25
Inclusion Criteria
- Patient with an advanced of metastatic, well-differentiated
gastroenteropancreatic neuroendocrine tumor .
- Indication for treatment with PRRT with 7.4 GBq 177Lu-DOTATATE by the
multidisciplinary team.
- Age >= 18 years.
Exclusion Criteria
- Failure to obtain informed concent.
- Patient received ionizing radiation for imaging purposes within one week
prior to PRRT or ionizing radiation for therapeutic purposes within 3 months
prior to PRRT.
- Previous treatment with PRRT.
- Indication to receive a lower activity of PRRT than 7.4 GBq.
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>This is a pilot study to validate the possibility of determining the effect of<br /><br>PRRT with 177Lu-DOTATATE on transcriptional regulation and DNA damage<br /><br>induction in PBMCs and how this is related to the radiation dose. </p><br>
- Secondary Outcome Measures
Name Time Method <p>To see if it is possible to detect ctDNA in NET patients.<br /><br><br /><br>Exploratory objectives<br /><br>- Evaluate the effect of PRRT on ctDNA levels<br /><br>- Discover genetic biomarkers of PRRT-induced NET damage by methylation<br /><br>sequencing.</p><br>