Comparing dosimetry-based and standard dose treatments for neuroendocrine neoplasms

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.