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Absorbed Tumor Dose in Peptide Receptor Radionuclide Therapy with Long-acting Somatostatin Analogues - ATSA Trial

RECRUITINGPhase 2/3Sponsored by The Netherlands Cancer Institute
Actively Recruiting
PhasePhase 2/3
SponsorThe Netherlands Cancer Institute
Started2024-06-25
Est. completion2027-01-01
Eligibility
Age18 Years+
Healthy vol.Accepted

Summary

According to current guidelines, patients have to withhalt long-acting somatostatin analogues (LA-SSA) for 4-6 weeks prior to every 177Lutetium-DOTATATE administration. The primary objective of the study is to investigate the effect of LA-SSA on the absorbed dose in tumor lesions during PRRT.

Eligibility

Age: 18 Years+Healthy volunteers accepted
Inclusion Criteria:

* Age ≥ 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.

Exclusion Criteria:

* 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.).

Conditions5

CancerNeuroendocrine NeoplasmNeuroendocrine Tumor Grade 1Neuroendocrine Tumor Grade 2Neuroendocrine Tumors

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