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177Lu-PP-F11N for Receptor Targeted Therapy and Imaging of Metastatic Thyroid Cancer.

NCT02088645 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2026-05-01

No results posted yet for this study

Summary

The purpose of this study is to determine the use of 177Lu-PP-F11N for imaging and therapy of patients with advanced medullary thyroid carcinoma (MTC). 177Lu-PP-F11N is a gastrin analogon, binding to cholecystokinin-2 receptors. This receptors show an overexpression on more than 90 % of medullary thyroid carcinomas.

In the pilot (phase 0) study investigators will correlate the tumour detection rate with the surgery and histology (proof of concept study). Furthermore, kidney protection and dosimetry studies will be performed in order to determine the kidney protection protocol and starting activity for the dose escalation study in the following, dose escalation (phase I) study. In the phase I study investigators will determinate the maximum tolerated dose of 177Lu-PP-F11N in patients with MTC. Furthermore, correlation with tumour radiation dose and treatment response as well as organ radiation doses and maximal tolerated dose will be performed in order to allow prospective individual patient tailored therapy planning. In the phase I study, participation is additionally possible for patients with well differentiated GEP-NET (grade 1-3) with a Ki67 index of up to 55% or NET of the lung or thymus (grade 1 and 2).

Conditions

  • Thyroid Cancer, Medullary
  • Neuroendocrine Tumor of the Lung Grade 1 and 2
  • Neuroendocrine Tumor of the Thymus Grade 1 and 2
  • Neuroendocrine Tumor GEP Grade 1-3

Interventions

DRUG

177Lu-PP-F11N

Sponsors & Collaborators

  • Krebsforschung Schweiz, Bern, Switzerland

    collaborator OTHER

  • Center for Proton Therapy, Paul Scherrer Institute, Villigen,Switzerland

    collaborator OTHER

  • University Hospital, Zürich

    collaborator OTHER

  • University Hospital Freiburg

    collaborator OTHER

  • University Hospital, Basel, Switzerland

    lead OTHER

Principal Investigators

  • Christof Rottenburger, Dr. med. · University Hospital, Basel, Switzerland

  • Damian Wild, Prof Dr Dr · University Hospital, Basel, Switzerland

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-04-30
Primary Completion
2027-04-30
Completion
2028-04-30

Countries

  • Switzerland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02088645 on ClinicalTrials.gov