Actively Recruiting
Absorbed Tumor Dose in Peptide Receptor Radionuclide Therapy with Long-acting Somatostatin Analogues - ATSA Trial
Led by The Netherlands Cancer Institute · Updated on 2025-03-03
39
Participants Needed
1
Research Sites
8 weeks
Total Duration
On this page
Sponsors
T
The Netherlands Cancer Institute
Lead Sponsor
N
Neuroendocrine Tumor Research Foundation
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are investigating the impact of long-acting somatostatin analogues (LA-SSA) on the absorbed radiation dose in tumor lesions during peptide receptor radionuclide therapy (PRRT) for patients with neuroendocrine tumors grade I and II. The study explores whether continuing or stopping LA-SSA treatment before PRRT affects tumor radiation absorption, following current guidelines that recommend withholding LA-SSA 4-6 weeks before PRRT administration. Participants are randomized into three groups: one group has not received LA-SSA treatment for at least three months before PRRT, the second group discontinues LA-SSA 4-6 weeks before PRRT, and the third group receives PRRT within one week after their most recent LA-SSA injection. The treatment involves administering 177Lutetium-DOTATATE with scheduled imaging and blood sample collections to assess drug effects and radiation dose. During the trial, participants undergo SPECT/CT scans at 4 hours, 24 hours, and between 5 to 7 days after injection to measure absorbed doses in tumors and normal tissues. Blood samples are also collected at multiple timepoints to study pharmacokinetics. Researchers monitor clinical status and performance scores, with the primary outcome focusing on tumor radiation absorption. The study runs until March 2027, with careful follow-up to evaluate treatment impact and safety.
CONDITIONS
Brief Title
Absorbed Tumor Dose in Peptide Receptor Radionuclide Therapy with Long-acting Somatostatin Analogues - ATSA Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 63; 18 years
- Able to provide spoken and written informed consent for the trial
- Histopathological confirmed neuroendocrine tumor
- Fulfill the clinical criteria for PRRT
- At least one soft tissue lesion > 2 cm
- Aimed administered activity of 7400 MBq
- ECOG score (performance status) 0-2
You will not qualify if you...
- Not possible to discontinue LA-SSA for 4-6 weeks
- Use of short-acting SSAs
- Pregnancy and lactating female patients
- Inability to comply to the study procedures
- Factors that might affect the biodistribution (for example, indication for furosemide directly after PRRT infusion, limited fluid intake, any renal catheters, etc.)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Duration of PRRT treatment cycles as per local protocol
Participants receive peptide receptor radionuclide therapy (PRRT) with either continued or discontinued long-acting somatostatin analogue (LA-SSA) treatment prior to PRRT according to their assigned group.
Visits for PRRT administration and imaging assessments after each PRRT injection
Duration - Up to 7 days after each PRRT injection
Participants undergo imaging and blood sample assessments to evaluate the effect of LA-SSA on absorbed tumor dose and pharmacokinetics after PRRT.
Multiple imaging and blood sample visits at 4 hours, 24 hours, and 5 to 7 days post-injection
Trial Site Locations
Total: 1 location
1
Antoni van Leeuwenhoek
Amsterdam, Netherlands
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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