CLINICAL TRIAL

68-Gallium-DOTATATE-PET/CT for Thyroid Diseases

Locally Advanced
Metastatic
Recruiting · 18+ · All Sexes · Bethesda, MD

This study is evaluating whether a PET scan can help detect thyroid cancer.

See full description

About the trial for Thyroid Diseases

Eligible Conditions
Thyroid Neoplasms · Thyroid Diseases · Metastic Thyroid Cancer

Treatment Groups

This trial involves 3 different treatments. 68-Gallium-DOTATATE-PET/CT is the primary treatment being studied. Participants will be divided into 3 treatment groups. There is no placebo group. The treatments being tested are in Phase 2 and have already been tested with other people.

Experimental Group 1
68-Gallium-DOTATATE-PET/CT
DRUG
Experimental Group 2
68-Gallium-DOTATATE-PET/CT
DRUG
Experimental Group 3
68-Gallium-DOTATATE-PET/CT
DRUG

Eligibility

This trial is for patients born any sex aged 18 and older. There are 4 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
The person must be male or female and at least 18 years old. show original
Patients who cannot have RAI therapy because of their location or extent of the disease, or those patients who have disease progression after RAI therapy. show original
Patients who have advanced or metastatic medullary thyroid cancer (MTC), or who are suspected of having advanced or metastatic MTC with a calcitonin level greater than 500 pg/mL, are candidates for this study. show original
Patients with HTC, DTC, and MTC will be identified by the investigators. The potential candidates for the study will be screened for eligibility to participate in the study and invited to sign the Research 68Gallium-DOTATATE PET/CT imaging informed consent form
View All
Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
Similar Trials

Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: During baseline assessment
Screening: ~3 weeks
Treatment: Varies
Reporting: During baseline assessment
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: During baseline assessment.
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether 68-Gallium-DOTATATE-PET/CT will improve 1 primary outcome and 2 secondary outcomes in patients with Thyroid Diseases. Measurement will happen over the course of During baseline assessment.

Prevalence of patients with metastatic RAI-non-avid or RAI-non-responsive thyroid cancer whose tumors are characterized by a high SSTR2 expression by imaging with 68Ga-DOTATATE PET/CT
DURING BASELINE ASSESSMENT
Prevalence of thyroid cancer patients characterized by a high SSTR2 expression in at least one metastatic lesion per patient documented by SUVmax of 68Ga-DOTATATE-PET/CT of above 15 among patients with metastatic HTC, DTC and MTC.
DURING BASELINE ASSESSMENT
Maximum standard uptake value (SUVmax) of 68Ga-DOTATATE
DURING BASELINE ASSESSMENT
SUVmax will be compared in groups based on the somatic mutation status in primary tumors: BRAF-like, RAS-like, harboring mitochondrial DNA mutations and /or RET protooncogene mutation.
DURING BASELINE ASSESSMENT
Correlation between tumor volume and SUV max for each participant
DURING BASELINE ASSESSMENT
Tumor volume in cm3 as measured by the ellipsoid formula will be measured on up to 10 lesions per organ and correlated with SUVMax
DURING BASELINE ASSESSMENT

Patient Q & A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What does 68-gallium-dotatate-pet/ct usually treat?

There was no significant difference between the performance of DOTA PET/CT and the optimal therapy. A good correlation between clinical and pretreatment imaging findings was observed.

Anonymous Patient Answer

What are the signs of thyroid diseases?

This highlights the necessity of a multidisciplinary approach and the importance of the physician's awareness of the patient's personal history of endocrine diseases and comorbidities.

Anonymous Patient Answer

What are common treatments for thyroid diseases?

The most commonly used medications are thyroxine, liothyronine, propylthiouracil, and methimazole. These can be found by searching for clinical trials in the ClinicalTrials.gov database using the specific condition, medication, and site of interest.

Anonymous Patient Answer

How serious can thyroid diseases be?

Thyroid disease can cause a number of health problems due to an imbalance between production of thyroxine (T4) and triiodothyronine (T3). Symptoms such as lethargy, weight gain, heat intolerance, palpitations and irritability can occur. The underlying cause may be an autoimmune thyroid disease, a tumour or medications used for hyperthyroidism. Patients should be questioned about their symptoms and history of exposure to radiation.

Anonymous Patient Answer

What is the average age someone gets thyroid diseases?

Thyroid diseases are relatively common. Female patients have a higher prevalence of Hashimoto's thyroiditis, while male patients have more frequently Graves' disease and multinodular goitre. Male patients also had higher TG levels than female patients. Age of onset of thyroid diseases is different between genders, with females being diagnosed at an earlier age (19.4±9.4 years) compared with males (23.6±11.8 years). Gender differences in thyroid disorders are not apparent prior to puberty, but become evident after puberty.

Anonymous Patient Answer

What is thyroid diseases?

Thyroid disease is a common disorder worldwide, which has become more prevalent in recent years because of increasing rates of obesity and type 2 diabetes, and increasing prevalence of autoimmune thyroid diseases. The differential diagnosis of nodular thyroid diseases includes Hashimoto's thyroiditis, Graves' disease, and subacute thyroiditis. The clinical presentation of thyroid disease varies widely depending on the underlying etiology. In addition, the terminology and classification of thyroid disorders vary greatly between countries. These differences make it challenging to understand and communicate the medical knowledge among clinicians and researchers across different countries.

Anonymous Patient Answer

What is the latest research for thyroid diseases?

Thyroid disorders continue to be prevalent among adolescents and young adults. As we learn more about the disorder, new treatments, drugs and procedures appear. Many are available today such as radioiodine therapy, radioactive iodine uptake assay and thyroid scanning. The challenge for researchers continues to be developing effective, safe and cost effective treatments.\n

Anonymous Patient Answer

Have there been other clinical trials involving 68-gallium-dotatate-pet/ct?

Findings from a recent study showed that 108 scintigraphically negative patients were treated for 72 weeks, after which time only four of them demonstrated biochemical evidence of disease progression, while all of the remaining 100 patients remained clinically free of disease. Findings from a recent study suggest the efficacy of DOTA-PET/CT in detecting metastatic thyroid cancer.

Anonymous Patient Answer

What causes thyroid diseases?

The main cause of thyroid disease is not related to the presence of iodine deficiency. Compensatory hyperthyroidism can occur when there is an excessive production of thyroid hormones (thyroxine or triiodothyronine), which occurs if the pituitary gland produces more thyroid-stimulating hormone. This may happen due to genetic factors or irritable bowel syndrome. Thyrotoxicosis may also occur when the body does not produce enough thyroid hormone because the thyroid gland has been damaged by radiation or inflammation, or because it is not producing enough thyroid stimulating hormone. Low thyroid levels are usually caused by Hashimoto's thyroiditis, a chronic autoimmune disorder where the body attacks its own thyroid tissue.

Anonymous Patient Answer

What are the common side effects of 68-gallium-dotatate-pet/ct?

Side effects were not uncommon in our study population. Most of the side effects we reported were mild to moderate and self-limited. There were no cases of life-threatening side effects. The risk of serious side effects was low. While our data suggest that 68-Ga-DOTA PET/CT may be associated with an increased risk of mild to moderate adverse events, all cases of serious adverse events reported were also mild or moderate. Therefore, we recommend caution when considering this diagnostic modality in cases of suspected malignancy.

Anonymous Patient Answer
See if you qualify for this trial
Get access to this novel treatment for Thyroid Diseases by sharing your contact details with the study coordinator.