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

April 30, 2026 updated by: University Hospital, Basel, Switzerland

177Lu-PP-F11N for Receptor Targeted Therapy and Imaging (Theranostics) of Metastatic Medullary Thyroid Cancer - a Pilot and a Phase I Study.

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).

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

24

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Basel, Switzerland, 4031
        • University Hospital Basel, Clinic for radiology and nuclear medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

Phase 0 study

  • Advanced MTC with elevated levels of calcitonin (> 100 pg/ml) and/or calcitonin-doubling time < 24 months before or after total thyroidectomy or
  • 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) with low or missing expression of SST2-receptor and progressive disease within the last 6 months according to RECIST 1.1
  • Age > 18 years
  • Informed consent

Phase I study

  • Diagnostic, contrast medium enhanced CT scan neck/thorax/abdomen, not older than 4 weeks
  • Advanced MTC with elevated levels of calcitonin (> 100 pg/ml) and/or calcitonin-doubling time < 24 months before or after total thyroidectomy- Age > 18 Years
  • Informed consent
  • Curative surgical therapy not possible

Exclusion Criteria:

Phase 0 study

  • Medication with Vandetanib 3 weeks before the study and during the study
  • Renal failure (calculated glomerular filtration rate (GFR) < 60 ml/min per 1.73 m2 body surface).
  • Bone marrow failure (thrombocytes < 70 000/μl, leucocytes < 2 500/μl, hemoglobin < 8 g/dl).
  • Pregnancy and breast feeding
  • Knows allergic reaction on Physiogel or other gelatine products
  • Known, serious side reaction in the case of a former application of pentagastrin
  • Active, second malignancy oder remission after second malignancy < 5 years

Phase I study

  • Medication with Vandetanib 3 weeks before the study and during the study
  • Renal failure (calculated GFR < 50 ml/min per 1.73 m2 body surface).
  • Bone marrow failure (thrombocytes < 100 000/μl, leucocytes < 3 000/μl, hemoglobin < 10 g/dl).
  • Pregnancy and breast feeding
  • Known, serious side reaction in the case of a former application of pentagastrin
  • Active, second malignancy oder remission after second malignancy < 5 years

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Phase 0: One arm; Phase I: One arm

Phase 0: 6 patients, intravenous application of 2 x 1 gigabequerel (GBq) 177Lu-PP-F11N with and without Physiogel (crossover)

Phase I: expected 12 - 18 patients, intravenous application of max. 6 x 7-8 GBq 177Lu-PP-F11N (increasing number of applications by one in groups of three patients). All patients with or without Physiogel, depending on the results of the phase 0 study.
Drug: 177Lu-PP-F11N
Other Names:
  • Minigastrin analogue
  • Gastrin analogue
  • Cholecystokinin-2 receptor ligand

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Phase 0: Scintigraphic visualisation rate
Time Frame: up to 4 weeks
Phase 0 study: Evaluation of the scintigraphic visualisation of metastases after test injection, verification of 177Lu-PP-F11N uptake in metastases and correlation with surgery/histology if possible (poof of principle study).
up to 4 weeks
Phase I: Maximum tolerated dose
Time Frame: Up to 9 months
Phase I study: Determination of the maximum tolerated dose (MTD)
Up to 9 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Phase 0: Tumour-to-kidney radiation doses
Time Frame: 8 and 16 weeks
Evaluation of the kidney radiation dose and the tumour-to-kidney radiation dose ratios with and without kidney protection (Physiogel). Composite measure.
8 and 16 weeks
Phase 0: Radiation doses
Time Frame: 8 and 16 weeks
Calculation of tumour and organ radiation doses.
8 and 16 weeks
Phase 0: In vivo stability
Time Frame: 8 and 16 weeks
Evaluation of in vivo stability of 177Lu-PP-F11N.
8 and 16 weeks
Phase 0: Metabolites
Time Frame: 8 and 16 weeks
Measurement of the metabolites of 177Lu-PP-F11N with and without Physiogel infusion.
8 and 16 weeks
Phase I: Side reactions
Time Frame: 8, 16 and 24 weeks
Evaluation of side reactions of 177Lu-PP-F11N.
8, 16 and 24 weeks
Phase 1: Biochemical response
Time Frame: For the duration of 24 months.
Evaluation of biochemical response (decrease of calcitonin and calculation of calcitonin doubling time).
For the duration of 24 months.
Phase I: Morphological response
Time Frame: 0, 3 and 12 months
Evaluation of morphological therapy response (RECIST criteria).
0, 3 and 12 months
Phase I: Tumour detection rate
Time Frame: 8, 16 and 24 weeks
Determination of the tumour detection rate and correlation with surgery/histology, if possible.
8, 16 and 24 weeks
Phase I: Organ radiation doses
Time Frame: 8, 16 and 24 weeks
Calculation of organ radiation doses after therapy and correlation with the determined MTD (composite measure).
8, 16 and 24 weeks
Phase 1: Overall survival
Time Frame: Up to 5 years
Determination of overall survival of patients after therapy.
Up to 5 years
Phase 1: In vivo stability
Time Frame: 8, 16 und 24 weeks
Evaluation of in vivo stability of 177Lu-PP-F11N.
8, 16 und 24 weeks
Phase 1: Metabolites
Time Frame: 8, 16 and 24 weeks
Measurement of the metabolites of 177Lu-PP-F11N.
8, 16 and 24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Basel, Switzerland

Collaborators

University Hospital, Zürich
University Hospital Freiburg
Krebsforschung Schweiz, Bern, Switzerland
Center for Proton Therapy, Paul Scherrer Institute, Villigen,Switzerland

Investigators

  • Principal Investigator: Christof Rottenburger, Dr. med., University Hospital, Basel, Switzerland
  • Study Director: Damian Wild, Prof Dr Dr, University Hospital, Basel, Switzerland

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2015

Primary Completion (Estimated)

April 1, 2027

Study Completion (Estimated)

April 1, 2028

Study Registration Dates

First Submitted

February 19, 2014

First Submitted That Met QC Criteria

March 14, 2014

First Posted (Estimated)

March 17, 2014

Study Record Updates

Last Update Posted (Actual)

May 1, 2026

Last Update Submitted That Met QC Criteria

April 30, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KFS-3170-02-2013

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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