NCT05507775Completed
Digoxin for the Reinduction of Radioiodine Uptake in Metastatic or Locally Advanced Non-medullary Thyroid Carcinoma
Source: ClinicalTrials.gov · Last updated 11 Apr 2024
Brief summary (registry, in English)
Non-medullary thyroid carcinoma has a good prognosis in most patients. However, a small subset of patients nevertheless develop metastatic or locally advanced and unresectable disease which in some cases also becomes radioiodine refractory. In these patients treatment options are very limited. Earlier cell line and animal studies have shown that digoxin can reinduce radioiodine uptake in non-medullary thyroid cancer. This study serves as a proof of principle study to assess the possibility of digoxin to reinduce radioiodine uptake in adult humans with metastatic or locally advanced non-medullary radioiodine refractory thyroid carcinoma.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 8 (actual)
- First submitted
- 17 Aug 2022
- Start date
- 6 Dec 2022
- Primary completion date
- 21 Jun 2023
- Lead sponsor
- Radboud University Medical Center
- Diseases
- Thyroid cancer
- NCT number
- NCT05507775
What you commit to
- Study type: Interventional
- Participants enrolled: 8
- From 6 Dec 2022 to the primary completion date, 21 Jun 2023
- 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
- Concomitant drugs that interfere with digoxin metabolism such as P-glycoprotein inductors or inducers, including but not limited to penicillamine, sulfasalazin, tipranavir, amiodarona, diltiazem, itraconazole, ketoconazole, kinidin, lapatinib, propafenon, vemurafenib, verapamil, azithromycin, clarithromycin, erythromycin, roxithromycin, chloroquin, ciclosporin, anti hepatitis C drugs, anti-HIV drugs, hydroxychloroquine.
- Prior therapy with radioactive iodine \<6 months prior to participation.
- External beam radiation therapy \<4 weeks prior to participation.
- Having undergone chemotherapy or targeted therapy \<4 weeks prior to participation.
- Use of other investigational drugs within 4 weeks preceding the first dose of digoxin treatment.
Other illness
- Cardiac arrhythmias
- Electrolyte disorder
- Known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to digoxin.
- Uncontrolled intercurrent illness that would limit compliance with the study requirements.
- Other active malignancies other than basal cell carcinoma. Malignancies that have been in complete remission over 2 years are not considered active malignancies.
- Rapidly progressive disease in which urgent start with systemic therapy is required.
Lab values
- Creatinine clearance \<50ml/min and/or active kidney disease
Other
- Pregnancy, lactating or breast-feeding women.
- Having undergone a procedure with iodine contrast agent within the last 3 months.
- Eastern Cooperative Oncology Group (ECOG) score \>2.
- Unwillingness or inability to comply with study and follow-up procedures.
Who the study is looking for
- Non-medullary thyroid carcinoma
- Having undergone total thyroidectomy and at least 1 treatment with \[131\]sodium iodine (NaI)
- Presence of local or metastatic disease, radiologically proven. A minimum of 1 target lesion (at least 1cm for soft tissue and 1.5cm for lymph nodes) must be present.
- Radioiodine refractory disease; at least one lesion without therapeutic relevant uptake at previous post-therapeutic scintigraphy and/or negative diagnostic \[123\]NaI-scan.
- The target lesion must not be eligible for local treatments.
- Hematologic lab values should be at least: absolute neutrophil count \>1.4x10\^9/liter, hemoglobin\>5.5mmol/liter, thrombocytes \>99x10\^9/liter
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 |
|---|---|---|---|
| Radboud University Medical Center Coordinator of this site? Confirm its status | Nijmegen | Netherlands | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.