💬In plain words
What the trial is, and whether it could suit you
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
Sign in to get the eligibility rules as simple questions to take to your doctor.
📋 Eligibility rules (as published)
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
Aarhus University Hospital, department of Nuclear medicine and PET centre
Aarhus, Denmark
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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