Comparing dosimetry-based and standard dose treatments for neuroendocrine neoplasms
Dosimetry Based PRRT Versus Standard Dose PRRT With Lu-177-DOTATOC in NEN Patients- a Randomized Study; a Step Towards Tailored PRRT
This study is testing if giving personalized doses of a treatment for neuroendocrine tumors based on kidney function works better than the standard dose.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Aarhus Academic / other |
| Drugs / interventions | sunitinib, chemotherapy |
| Locations | 1 site (Aarhus, Palle Juul-Jensens Boulevard) |
| Trial ID | NCT04917484 on ClinicalTrials.gov |
What this trial studies
This study aims to randomize patients with neuroendocrine neoplasms (NENs) eligible for peptide receptor radionuclide therapy (PRRT) into two groups: one receiving a standard dose of Lu-177-DOTATOC and the other receiving individualized doses based on kidney function and previous treatment responses. Patients in the dosimetry arm will have their first dose tailored to their kidney function, with subsequent doses adjusted based on absorbed kidney dose from prior treatments. All patients will undergo SPECT/CT scans to monitor kidney dose absorption, ensuring safety and efficacy throughout the treatment process.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with confirmed neuroendocrine neoplasms who have shown progression despite standard treatments.
Not a fit: Patients who do not have adequate kidney function or who are not experiencing progression of their neuroendocrine neoplasms may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to more effective and safer treatment options for patients with neuroendocrine neoplasms.
How similar studies have performed: While the specific approach of individualized dosimetry in PRRT is relatively novel, similar studies have shown promising results in optimizing treatment for neuroendocrine tumors.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 1\. Male or female patients 18 years of age or more * 2\. NEN confirmed by histology * 3\. Clinical, PET/CT or CT proven progression despite standard treatment with somatostatin analogues, targeted therapy (Everolimus, sunitinib), chemotherapy (STZ/5-FU, temozolomide/capecitabine) OR intolerable side effects caused by these standard treatment OR unmanageable carcinoid symptoms * 4\. WHO/ ECOG Performance Status of 0-2 * 5\. Life expectancy more than 6 months * 6\. Uptake higher than liver in primary tumor or metastases on Ga-DOTATOC PET/CT (Krenning 3 or 4), if the scan is more than 3 months old at inclusion time, a new scan should be done. * 7\. Adequate organ function as defined by: * Adequate kidney function: Patient glomerular filtration rate \>30 ml/min measured by Tc-DTPA clearance * Adequate bone marrow function: * WBC ≥ 2.0 x 109/L * Platelets ≥ 100 x 109/L * Hb ≥ 6 mmol/l (≥9.67 g/dL) * 8\. Willingness and ability to comply with scheduled visits for SPECT/CT scans, treatment plans, laboratory tests and other study procedures. 9\. Written informed consent obtained prior to any screening procedures Exclusion Criteria: * 1\. Tumor amenable to surgery and/or radiofrequency ablation * 2\. Patients who are unable to stay isolated for 24 hours * 3\. Previous PRRT * 4\. Female patients who are pregnant or lactating. Women who are of childbearing potential (defined as all women physiologically capable of becoming pregnant) have to practice an effective method of contraception/birth control. Fertile female patients have to take a urinary pregnancy test, to ensure that they are not pregnant, before they can enter the study. After entering the study, they have to use effective contraception during the study period and 6 months after. Effective contraception methods include: * Use of oral, injected or implanted hormonal methods of contraception or * Placement of an intrauterine device (IUD) or intrauterine system (IUS) * Total abstinence or patient sterilization (male or female) * 5\. Male patients are not allowed to conceive pregnancy for 6 months after last treatment cycle * 6\. Known to be hypersensitive to any component of the Lu-177-DOTATOC * 7\. Patients with meningioma
Where this trial is running
Aarhus, Palle Juul-Jensens Boulevard
- Aarhus University Hospital, department of Nuclear medicine and PET centre — Aarhus, Palle Juul-Jensens Boulevard, Denmark (Recruiting)
Study contacts
- Study coordinator: Tine N Gregersen, MD, PhD
- Email: tigreg@rm.dk
- Phone: +4522334161
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.