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NCT Number: NCT02088645

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

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).

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Key information

Conditions

Thyroid Cancer, Medullary Adenocarcinoma Carcinoma Carcinoma, Medullary Carcinoma, Neuroendocrine Neoplasms Neoplasms by Histologic Type Neoplasms, Ductal, Lobular, and Medullary Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Neuroectodermal Tumors Neuroendocrine Tumor GEP Grade 1-3 Neuroendocrine Tumor of the Lung Grade 1 and 2 Neuroendocrine Tumor of the Thymus Grade 1 and 2 Neuroendocrine Tumors

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

University Hospital Basel, Clinic for radiology and nuclear medicine

Basel, 4031, Switzerland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

177Lu-PP-F11N

Drug

Other names: Minigastrin analogue, Gastrin analogue, Cholecystokinin-2 receptor ligand

Primary outcomes

  1. 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).

  2. Phase I: Maximum tolerated dose

    Time frame: Up to 9 months

    Phase I study: Determination of the maximum tolerated dose (MTD)

Secondary outcomes

  1. 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.

  2. Phase 0: Radiation doses

    Time frame: 8 and 16 weeks

    Calculation of tumour and organ radiation doses.

  3. Phase 0: In vivo stability

    Time frame: 8 and 16 weeks

    Evaluation of in vivo stability of 177Lu-PP-F11N.

  4. Phase 0: Metabolites

    Time frame: 8 and 16 weeks

    Measurement of the metabolites of 177Lu-PP-F11N with and without Physiogel infusion.

  5. Phase I: Side reactions

    Time frame: 8, 16 and 24 weeks

    Evaluation of side reactions of 177Lu-PP-F11N.

  6. 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).

  7. Phase I: Morphological response

    Time frame: 0, 3 and 12 months

    Evaluation of morphological therapy response (RECIST criteria).

  8. 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.

  9. 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).

  10. Phase 1: Overall survival

    Time frame: Up to 5 years

    Determination of overall survival of patients after therapy.

  11. Phase 1: In vivo stability

    Time frame: 8, 16 und 24 weeks

    Evaluation of in vivo stability of 177Lu-PP-F11N.

  12. Phase 1: Metabolites

    Time frame: 8, 16 and 24 weeks

    Measurement of the metabolites of 177Lu-PP-F11N.

Sponsors and collaborators

Lead sponsor

University Hospital, Basel, Switzerland

Other

Collaborators

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

Registry information

Official study title

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

Acronym: Lumed

Important dates

Study start
2015
Primary completion
2027
Study completion
2028
First posted
Mar 17, 2014
Registry last updated
May 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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