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

Study Purpose

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 we 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 we 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.

Recruitment Criteria

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Accepts Healthy Volunteers
No

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.

An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.

Study Type
Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

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 - 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 < 70 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 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

Trial Details

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

Trial ID:
NCT02088645

Phase 0: Exploratory study involving very limited human exposure to the drug to determine whether a drug is modulating its target.

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase
Phase 1

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Lead Sponsor
University Hospital, Basel, Switzerland

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Agency Class
OtherOtherOtherOtherOther
Overall Status Recruiting
Countries Switzerland

The disease, disorder, syndrome, illness, or injury that is being studied.

Conditions
Thyroid Cancer, Medullary

Contact a Trial Team

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International Sites

Basel, Switzerland

Status

Recruiting

Address

University Hospital Basel, Clinic for radiology and nuclear medicine

Basel, , 4031

Site Contact

Christof Rottenburger, Dr. med.

christof.rottenburger@ubs.ch

0041613286551

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