NCT02088645Active, not recruitingPhase 1
177Lu-PP-F11N for Receptor Targeted Therapy and Imaging of Metastatic Thyroid Cancer.
177Lu-PP-F11N for Receptor Targeted Therapy and Imaging (Theranostics) of Metastatic Medullary Thyroid Cancer - a Pilot and a Phase I Study.
Source: ClinicalTrials.gov · Last updated 1 May 2026
Brief summary (registry, in English)
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).
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 24 (estimated)
- First submitted
- 19 Feb 2014
- Start date
- Apr 2015
- Primary completion date
- Apr 2027
- Lead sponsor
- University Hospital, Basel, Switzerland
- Diseases
- Thyroid cancer, Neuroendocrine tumours, Lung cancer
- NCT number
- NCT02088645
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 24
- From Apr 2015 to the primary completion date, Apr 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Medication with Vandetanib 3 weeks before the study and during the study
- Medication with Vandetanib 3 weeks before the study and during the study
Other illness
- Knows allergic reaction on Physiogel or other gelatine products
Lab values
- 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).
- 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).
Age
- Active, second malignancy oder remission after second malignancy \< 5 years
- Phase I study
- Active, second malignancy oder remission after second malignancy \< 5 years
Other
- Phase 0 study
- Pregnancy and breast feeding
- Known, serious side reaction in the case of a former application of pentagastrin
- Pregnancy and breast feeding
- Known, serious side reaction in the case of a former application of pentagastrin
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University Hospital Basel, Clinic for radiology and nuclear medicine Coordinator of this site? Confirm its status | Basel | Switzerland | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.