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Comparison of I-124 PET/CT for the Diagnosis of Thyroid Cancer

ConditionThyroid Cancer
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age13+
SponsorThomas Hope

About this trial

Persons diagnosed with thyroid cancer are often treated initially with a thyroidectomy, which is followed by ablation using Iodine-131, a therapy which has been shown to be effective and safe. Imaging of metastatic thyroid cancer has been performed with whole body I-131 and Iodine 123 (I-123) imaging for many decades and use I-123 for staging studies. Iodine 124 (I-124) is a radioisotope of iodine which emits a positron and is imaged using PET (positron emission tomography). This is a single arm prospective trial that evaluates the ability of Iodine-124 (I-124) to detect metastatic thyroid cancer compared to non-interventional, usual care I-123 and I-131 images.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age >= 13 years.

Histopathologically confirmed differentiated or poorly differentiated thyroid cancer.

American Thyroid Association (ATA) intermediate or high-risk thyroid cancer and planning on treatment using I-131.

Metastatic disease on imaging (CT, MRI, ultrasound or FDG PET), and considering localized therapy such as surgery and radiation therapy.

Disqualifiers

Unlikely to comply with study procedures, restrictions and requirements and judged by the Investigator to be unsuitable for participation.

Known pregnancy.

Trial design

Design model

Single group

Treatments tested in this trial

  • Iodine-124

    Drug

    Given Orally

  • Positron Emission Tomography (PET)/Computerized tomography (CT)

    Procedure/Surgery

    Combination of PET and CT imaging

Treatment groups

62 Participants
are divided into 1 treatment group
Group A: Intervention: I-124 PET/CTExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Proportion of agreement between I-124 PET and I-123/I-131 SPECT (participant)

Participant-level agreement between I-124 PET and the combination of I-123/I-131 SPECT will be measured. A participant will be classified as showing agreement only if all six regions demonstrate agreement; disagreement in one or more regions will result in a classification of disagreement. Positive percent agreement (PPA) and negative percent agreement (NPA) will be reported with corresponding 95% confidence intervals.

Time frame
1 day
2

Number of agreement between 1-124 PET and 1-123/1-131 SPECT (region)

Region-level agreement between 1-124 PET and the combination of 1-123/1-131 SPECT will be determined by Individual reader and through a consensus read. A region is in agreement if I-124 PET and I-123/I-131 SPECT results align, either as true positive (both positive) or true negative (both negative). Disagreement occurs when the results diverge, categorized as false positive (I-124 PET positive, but I-123/I-131 SPECT negative) or false negative (I-124 PET negative, but I-123/I-131 SPECT positive).

Time frame
1 day

Secondary outcomes

1

Overall specificity of I-124 PET for detection of metastatic thyroid cancer (participant)

Specificity of I-124 is defined as the proportion of lesions that will be characterized as negative on I-124 PET when compared to the composite truth standard across participants. The composite truth standard is determined by a panel of highly qualified physicians and researchers and will be used to determine true positive (TP), false positive (FP), true negative (TN) and false negative (FN) by participant: o TP: I-124 PET read as positive for tumor, and composite truth standard determined to have tumor. o FP: I-124 PET read as positive for tumor, and composite truth standard determined to not contain tumor. o TN: I-124 PET read as negative for tumor, and composite truth standard determined to not contain tumor. o FN: I-124 PET read as negative for tumor, and composite truth standard determined to contain tumor. Specificity ranges from 0 to 100%, with higher values indicating a better ability for the scan to detect healthy individuals

Time frame
1 day
2

Overall specificity of I-124 PET for detection of metastatic thyroid cancer (region)

Specificity of I-124 is defined as the proportion of lesions that will be characterized as negative on I-124 PET when compared to the composite truth standard by region. The composite truth standard is determined by a panel of highly qualified physicians and researchers and will be used to determine true positive (TP), false positive (FP), true negative (TN) and false negative (FN) by region: o TP: I-124 PET read as positive for tumor, and composite truth standard determined to have tumor. o FP: I-124 PET read as positive for tumor, and composite truth standard determined to not contain tumor. o TN: I-124 PET read as negative for tumor, and composite truth standard determined to not contain tumor. o FN: I-124 PET read as negative for tumor, and composite truth standard determined to contain tumor. Specificity ranges from 0 to 100%, with higher values indicating a better ability for the scan to detect healthy individuals

Time frame
1 day
3

Overall sensitivity of I-124 PET for detection of metastatic thyroid cancer (participant)

Sensitivity of I-124 is defined as the proportion of lesions that will be characterized as positive on I-124 PET when compared to the composite truth standard on a participant level. The composite truth standard is determined by a panel of highly qualified physicians and researchers and will be used to determine true positive (TP), false positive (FP), true negative (TN) and false negative (FN) across participants: o TP: I-124 PET read as positive for tumor, and composite truth standard determined to have tumor. o FP: I-124 PET read as positive for tumor, and composite truth standard determined to not contain tumor. o TN: I-124 PET read as negative for tumor, and composite truth standard determined to not contain tumor. o FN: I-124 PET read as negative for tumor, and composite truth standard determined to contain tumor. Sensitivity ranges from 0 to 100%, with higher values indicating a more sensitive scan.

Time frame
1 day
4

Overall sensitivity of I-124 PET for detection of metastatic thyroid cancer (region)

Sensitivity of I-124 is defined as the proportion of lesions that will be characterized as positive on I-124 PET when compared to the composite truth standard by region. The composite truth standard is determined by a panel of highly qualified physicians and researchers and will be used to determine true positive (TP), false positive (FP), true negative (TN) and false negative (FN) by region: o TP: I-124 PET read as positive for tumor, and composite truth standard determined to have tumor. o FP: I-124 PET read as positive for tumor, and composite truth standard determined to not contain tumor. o TN: I-124 PET read as negative for tumor, and composite truth standard determined to not contain tumor. o FN: I-124 PET read as negative for tumor, and composite truth standard determined to contain tumor. Sensitivity ranges from 0 to 100%, with higher values indicating a more sensitive scan.

Time frame
1 day

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Thomas Hope

Lead sponsor

University of California, San Francisco

Sponsor institution

United States Department of Defense

Collaborator

Source ClinicalTrials.gov
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