Clinical Trials Logo

Clinical Trial Summary

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.


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms


NCT number NCT04917484
Study type Interventional
Source University of Aarhus
Contact Tine N Gregersen, MD, PhD
Phone +4522334161
Email tigreg@rm.dk
Status Recruiting
Phase Phase 2
Start date February 1, 2020
Completion date December 2026

See also
  Status Clinical Trial Phase
Recruiting NCT04464122 - Rediscovering Biomarkers for the Diagnosis and Early Treatment Response in NEN (REBORN)
Active, not recruiting NCT03375320 - Testing Cabozantinib in Patients With Advanced Pancreatic Neuroendocrine and Carcinoid Tumors Phase 3
Active, not recruiting NCT03980925 - Platinum-doublet Chemotherapy and Nivolumab for the Treatment of Subjects With Neuroendocrine Neoplasms (NENs) of the Gastroenteropancreatic (GEP) Tract or of Unknown (UK) Origin. Phase 2
Recruiting NCT02402244 - Project: Every Child for Younger Patients With Cancer
Recruiting NCT05113355 - Chidamide Plus Sintilimab for Chemotherapy-refractory Advanced High-grade Neuroendocrine Neoplasm Phase 2
Recruiting NCT05879055 - A Study of PM8002 Injection in Combination With Chemotherapy in Patients With NEN Phase 2
Terminated NCT03001349 - 68Ga-DOTA-TOC PET/CT in Imaging Participants With Neuroendocrine Tumors Early Phase 1
Completed NCT02399215 - Nintedanib in Treating Patients With Locally Advanced or Metastatic Neuroendocrine Tumors Phase 2
Recruiting NCT05165407 - Sintilimab Combined With IBI310 and Surufatinib for the Treatment of G3-NET and NEC Phase 2
Recruiting NCT06337760 - YOUNg Adults With Gastro-inteSTinal (GI) and nEuroendocrine canceRs.
Recruiting NCT04927611 - Single-cell Sequencing and Establishment of Models in Neuroendocrine Neoplasm
Active, not recruiting NCT01638533 - Romidepsin in Treating Patients With Lymphoma, Chronic Lymphocytic Leukemia, or Solid Tumors With Liver Dysfunction Phase 1
Recruiting NCT02817945 - Dual SSTR2 and Integrin αvβ3 Targeting PET/CT Imaging Early Phase 1
Active, not recruiting NCT03950609 - Lenvatinib and Everolimus in Treating Patients With Advanced, Unresectable Carcinoid Tumors Phase 2
Active, not recruiting NCT04750954 - Testing the Addition of An Anti-cancer Drug, M3814 (Peposertib), to the Usual Radiation-Based Treatment (Lutetium Lu 177 Dotatate) for Pancreatic Neuroendocrine Tumors Phase 1
Active, not recruiting NCT02402920 - Pembrolizumab and Concurrent Chemoradiotherapy or Radiation Therapy in Treating Patients With Small Cell Lung Cancer Phase 1
Not yet recruiting NCT04931446 - Neuroendocrine Neoplasm Based on Multi-omics Integrated Analysis
Recruiting NCT06343428 - Definition of a Multiparametric Prognostic and Predictive System of Classification of NET G3 Patients
Recruiting NCT04720391 - Bone Metastases in neurOendocrine NEoplasms: naTural History, Prognostic Impact and Therapeutic Approach (MONET)
Recruiting NCT03734913 - A Phase 1 Study of ZSP1602 in Participants With Advanced Solid Tumors Phase 1