Clinical Trials
Open studies conducted by NIDDK Principal Investigators appear below. Study statuses may include the following:
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Open: Recruiting - Currently recruiting participants and open to everyone who meets eligibility criteria.
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Open: Active, Not Recruiting - Participants are receiving an intervention or being examined, however new participants
are not being recruited or enrolled.
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Open: Enrolling by Invitation - People in a particular population were selected in advance and invited to participate.
The study is not open to everyone who meets the eligibility criteria.
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Open: Available for Expanded Access - Patients who are not participants in the clinical study may be able to
gain access to the drug, biologic, or medical device being studied.
Studies Seeking Patients
Study rationale
High risk patients with differentiated thyroid cancer (DTC) require therapy with 131 I under
thyroid stimulating hormone (TSH) stimulation. There are two methods of TSH stimulation
endogenous by thyroid hormone withdrawal (THW) leading to hypothyroidism and exogenous by
injection of human recombinant TSH (rhTSH Thyrogen). The appropriate 131-I activity utilized
for treatment is either based on empiric fixed dosage choice or individually determined
activity based on 131 I dosimetric calculations. Although dosimetry utilizing radioactive
iodine isotope 131 I enables calculation of maximum safe dose, it does not estimate the
tumoricidal activity necessary to destroy the metastatic lesions. The alternative radioactive
isotope of iodine -124 I, used for positron emission tomography (PET) imaging, might be used
for calculation not only the maximum safe131 I dose, but also to predict the absorbed dose in
the metastatic lesions.
Study objectives
The primary objective of this study is to compare the 124 I -PET/CT lesional and whole body
dosimetry in each individual patient with metastatic radioiodine (RAI)-avid thyroid cancer
under preparation with rhTSH and THW. The secondary objective is to evaluate the predicted by
PET/CT lesional uptake with the early response to therapy.
Study design
This is a phase 2 pilot prospective cohort study comparing the lesional and whole body
dosimetry within each patient undergoing exogenous (rhTSH) and endogenous (THW) TSH
stimulation and followed for 5 years.
Interventions
Each study participant will undergo rhTSH and THW-aided 124 I-PET/CT dosimetric evaluations
and will be subsequently treated with THW-aided RAI activity based on dosimetric calculations
enabling maximum safe dosage. The patients will be followed in 12+/-3 months intervals for 5
years.
Sample size and population
This pilot study will include 30 patients with high risk differentiated thyroid cancer
presenting with distant and/or loco-regional metastases.
The trial is Open with a status of Recruiting.
Investigator:
Joanna Klubo-Gwiezdzinska, M.D.
Referral Contacts:
Padmasree Veeraraghavan, N.P.
(301) 451-7710
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Background:
- Researchers are studying types of thyroid cancer that seem to cluster in families.
Non-medullary thyroid cancer accounts for the vast majority of all types of thyroid cancer,
but little is known about possible genes that may cause the cancer. More research is needed
to develop the best ways to screen for familial non-medullary thyroid cancer (FNMTC) so that
it can be diagnosed and treated at an early stage.
Objectives:
- To evaluate the natural history of FNMTC.
- To determine the best screening strategy for FNMTC.
- To identify genes that may indicate susceptibility to FNMTC.
Eligibility:
- Individuals at least 7 years of age who have two first-degree relatives (e.g., parents,
children, siblings) who have or have had non-medullary thyroid cancer or a documented
diagnosis of non-medullary thyroid cancer and one living relative with documented
non-medullary thyroid cancer.
Design:
- Participants will be evaluated by family history pedigree, physical examination, imaging
(including possible neck ultrasound and radioactive iodine scans), and laboratory
testing.
- Participants who agree to have blood or other biological samples collected will be asked
to enroll in an additional study to provide the appropriate samples and tissues.
- After the initial study evaluation, participants who are not found to have a malignant
thyroid tumor will be re-screened every year with non-invasive imaging studies.
Participants who are found to have a malignant thyroid tumor will be informed of
possible treatment options.
The trial is Open with a status of Recruiting.
Investigator:
Joanna Klubo-Gwiezdzinska, M.D.
Referral Contacts:
Joanna Klubo-Gwiezdzinska, M.D.
(301) 496-5052
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Participants in this study will be patients diagnosed with or suspected to have a thyroid
function disorder. These conditions may include: hypothyroidism, hyperthyroidism, thyroid
hormone resistance, Graves' Dermopathy, and thyroid-stimulating hormone (TSH) secreting
pituitary adenomas.
The main purpose of this study is to further understand the natural history, clinical
presentation, and genetics of thyroid function disorders. Many of the tests performed are in
the context of standard medical care that is offered to all patients with thyroid function
disorders. In addition, blood and tissue samples may be taken for research and genetic
studies.
The trial is Open with a status of Recruiting.
Investigator:
Joanna Klubo-Gwiezdzinska, M.D.
Referral Contacts:
Padmasree Veeraraghavan, N.P.
(301) 451-7710
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Participants in this study will be patients diagnosed with or suspected to have a thyroid
nodule or thyroid cancer.
The main purpose of this study is to further understand the methods for the diagnosis and
treatment of thyroid nodules and thyroid cancer. Many of the test performed are in the
context of standard medical care that is offered to all patients with thyroid nodules or
thyroid cancer. Other tests are performed for research purposes. In addition, blood and
tissue samples will be taken for research and genetic studies.
The trial is Open with a status of Recruiting.
Investigator:
Joanna Klubo-Gwiezdzinska, M.D.
Referral Contacts:
Padmasree Veeraraghavan, N.P.
(301) 451-7710
Share this Trial:
Email
Facebook