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

ConditionsNeuroendocrine TumorsNeuroendocrine Tumor Grade 1Neuroendocrine Tumor Grade 2Neuroendocrine Neoplasm
Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorThe Netherlands Cancer Institute

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥ 18 years;

Able to provide spoken and written informed consent for the trial;

Histopathological confirmed neuroendocrine tumor;

Fulfill the clinical criteria for PRRT;

Disqualifiers

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;

Trial design

Design model

Parallel

Treatments tested in this trial

  • Somatostatin analog

    Drug

    Timing of LA-SSA injection prior to PRRT (either 4-6 weeks or 1-7 days).

Treatment groups

39 Participants
are divided into 3 treatment groups
Group A: ControlNo intervention 0 interventions
Group B: 2A - LA-SSA injection 4-6 weeks before PRRTActive comparator 1 intervention
Group C: 2B - LA-SSA injection 1-7 days before PRRTExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Effect of continued LA-SSA use on the absorbed dose in tumor lesions during PRRT.

Time frame
SPECT/CT after 4h, 24h, and 5-7 days post-injection

Secondary outcomes

1

Effect of continued LA-SSA use on the absorbed dose in normal tissues during PRRT.

Time frame
SPECT/CT after 4h, 24h, and 5-7 days post-injection and blood samples at 2h, 4h, 24h and 5-7 days post-injection
2

Effect of continued LA-SSA use on the tumor-to-background ratio.

Time frame
SPECT/CT after 4h, 24h, and 5-7 days post-injection
3

Effect of continued LA-SSA use on population pharmacokinetic parameters of [177Lu]Lu-HA-DOTATATE.

Time frame
Blood samples at 2h, 4h, 24h and 5-7 days post-injection

Other outcomes

1

HRQoL assessments

Time frame
At baseline, on the day of PRRT administration, 3 weeks after PRRT

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

The Netherlands Cancer Institute

Lead sponsor

Neuroendocrine Tumor Research Foundation

Collaborator

Source ClinicalTrials.gov
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