NCT04917484RecruitingPhase 2
Dosimetry Based PRRT Versus Standard Dose PRRT With Lu-177-DOTATOC in NEN Patients
Dosimetry Based PRRT Versus Standard Dose PRRT With Lu-177-DOTATOC in NEN Patients- a Randomized Study; a Step Towards Tailored PRRT
Source: ClinicalTrials.gov · Last updated 9 Dec 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
In this study, we want to randomize patients with neuroendocrine neoplasms (NENs) who are eligible for peptide receptor radionuclide therapy (PRRT), to either standard PRRT consisting of 4 treatments with 7.4 GBq Lu-177-DOTATOC (standard arm) or 4 treatments with individualized doses of Lu-177-DOTATOC (dosimetry arm). In the dosimetry arm, the first dose depends on the patients' kidney function and thereafter the absorbed dose to the kidneys at the previous treatment. A max of 20GBq will be administered at the first treatment and 25GBq at treatment 2-4. We aim to reach an accumulated kidney dose of 24Gy. After the first treatment all patients will go through three SPECT/CT scans 24 hours, 4 days, and 7 days, after treatment to calculate absorbed kidney dose. The patients in the standard dose treatment arm will have one SPECT/CT scan after each of the last three treatments; all performed 24 hours after treatment, used to approximate the kidney dose assuming the clearance of the Lu-177 DOTATOC is the same after all treatments. The patients in the dosimetry based treatment arm will go through three SPECT/CT scans after all four treatments for dosimetry calculation. Bone marrow dosimetry is calculated after all treatments in the dosimetry based treatment arm and after the first treatment in the standard treatment arm. For bone marrow dosimetry, blood samples are drawn right before administration of Lu-177 DOTATOC (time 0) and 3 minutes, 45 minutes, 2 hours, 4 hours, 7-8 hours, 24 hours, 4 days, and 7 days after administration of Lu-177 DOTATOC. Standard blood samples are routinely drawn every 2nd week after every treatment in all included patients and analysed regarding liver, kidney and bone marrow function. Kidney clearance is evaluated with Tc-DTPA clearance at baseline. Blood and urinary samples will be collected at baseline and 3 months after the last treatment for kidney fibrosis analyses. At baseline, blood and urine samples are collected for a biobank. All included patients fill in validated quality of life questionaires at all treatments. To evaluate the effect of the treatment, all patients will be evaluated with standard CT scans prior to treatment and 3 and 9 months after the 4th treatment. Ga-68 DOTATOC PET will be performed at baseline and 6 and 12 months after the last treatment.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 100 (estimated)
- First submitted
- 1 Sept 2020
- Start date
- 1 Feb 2020
- Primary completion date
- Dec 2025
- Lead sponsor
- Tine Gregersen, MD
- Diseases
- Neuroendocrine tumours
- NCT number
- NCT04917484
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 100
- From 1 Feb 2020 to the primary completion date, Dec 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 1\. Tumor amenable to surgery and/or radiofrequency ablation
- 3\. Previous PRRT
Other
- 2\. Patients who are unable to stay isolated for 24 hours
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Aarhus University Hospital, department of Nuclear medicine and PET centre Coordinator of this site? Confirm its status | Aarhus | Denmark | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.