Comparison of I-124 PET/CT for the Diagnosis of Thyroid Cancer
- Conditions
- Thyroid Cancer
- Interventions
- Drug: Iodine-124Procedure: Positron Emission Tomography (PET)/Computerized tomography (CT)
- Registration Number
- NCT06961084
- Lead Sponsor
- Thomas Hope
- Brief Summary
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.
- Detailed Description
PRIMARY OBJECTIVES:
1. Reclassification rate of I-124 Positron Emission Tomography (PET) compared to I-123 Single-photon emission computed tomography (SPECT).
2. Sensitivity and specificity of I-124 PET to detect metastatic thyroid cancer compared to composite standard.
SECONDARY OBJECTIVES:
1. Inter-reader variability for I-124 PET and I-123 SPECT.
2. Safety of I-124 PET.
3. Participant level detection rate for I-124 in the overall population.
4. Participant level detection rate for I-124 in participants who have negative I-123 SPECT.
5. Comparison of lesion detection between I-124 PET and 24 hour I-123 SPECT.
6. Comparison of lesion detection between I-124 PET and post-treatment I-131 SPECT.
EXPLORATORY OBJECTIVES
1) Ability to predict lesion absorbed dose using I-124 PET/CT.
OUTLINE:
All participants will have a single PET/CT scan after administration of I-124 and will be followed for up to 3-5 days by phone for evaluation of adverse events. A subset of participants being evaluated for dosimetry will be imaged up to two additional times over five days after administration. Data from other scans for comparison will be obtained from the participant's medical record.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 58
-
Age >= 18 years.
-
Histopathologically confirmed differentiated thyroid cancer, with clinical concern for metastatic disease, which is based on:
- Metastatic disease seen on I-123 SPECT, Fluorodeoxyglucose (FDG) PET, CT scan or ultrasound.
- Elevated thyroglobulin in participant after total thyroidectomy.
i. Participants with an undetectable thyroglobulin will be allowed if thyroglobulin antibodies are present.
-
Planned I-123 imaging within 45 days after enrollment.
-
Ability to understand a written informed consent document, and the willingness to sign it.
- Unlikely to comply with study procedures, restrictions and requirements and judged by the Investigator to be unsuitable for participation.
- Known pregnancy, per institutional policy.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Intervention: I-124 PET/CT Iodine-124 All participants will be administered an oral dose of 60 to 85 megabecquerel (MBq) +/- 10% for I-124 (capsule) prior to the Positron Emission Tomography (PET) imaging. Scan coverage will extend from the vertex to the mid-thighs and in certain circumstances, coverage may be extended to the toes. Imaging will be acquired 20-28 hours after I-124 administered. Participants will be followed up for any adverse events for up to 5 days after the scan has been completed. Intervention: I-124 PET/CT Positron Emission Tomography (PET)/Computerized tomography (CT) All participants will be administered an oral dose of 60 to 85 megabecquerel (MBq) +/- 10% for I-124 (capsule) prior to the Positron Emission Tomography (PET) imaging. Scan coverage will extend from the vertex to the mid-thighs and in certain circumstances, coverage may be extended to the toes. Imaging will be acquired 20-28 hours after I-124 administered. Participants will be followed up for any adverse events for up to 5 days after the scan has been completed.
- Primary Outcome Measures
Name Time Method Reclassification Rate 1 day Reclassification rate is defined as the proportion of participants what will be characterized as metastatic on I-124 Positron Emission Tomography (PET) that are characterized as localized or nodal only disease on a non-investigational, usual care I-123 Single-photon emission computed tomography (SPECT).
Overall sensitivity of I-124 PET to detect metastatic thyroid cancer (region) 1 day 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. 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.
Overall specificity of I-124 PET to detect metastatic thyroid cancer (region) 1 day 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. 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
- Secondary Outcome Measures
Name Time Method The proportion of lesions characterized as positive on I-124 PET and 24 hour I-123 SPECT 1 day The total number of lesions detected for each participant using I-124 and I-123 (with a maximum of 10 lesions per region) will be compared and the proportion of all participants with lesions characterized by a consensus read as positive on both on I-124 PET and positive on 24 hour I-123 SPECT.
Proportion of lesions characterized as positive on both I-124 PET and 7-day post I-131 1 day The total number of lesions detected for each participant using I-124 and I-123 (with a maximum of 10 lesions per region) will be compared and the proportion of all participants with lesions characterized by a consensus read as positive on both on I-124 PET and positive on 7-day post I-131 imaging
Inter-reader reliability (IRR) for I-124 PET 1 day Three blinded readers will interpret the non-investigational, usual care I-123 imaging and the I-124 imaging. A Cohen's Kappa will be used to measure the inter-reader variability for I-124 and I-123 separately. Kappa statistics range from -1 to 1 with higher values correspond to higher inter-rater reliability.
Proportion of participants with treatment-related adverse events Up to 5 days Proportion of participants with treatment-related adverse events, as classified and graded by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE version 5.0
Proportion of participants with positive I-124 PET in the overall population 1 day The participant level detection rate will be assessed by calculating the number of participants interpreted as having a positive I-124 PET divided by the total number of participants with a scan evaluated by a reader.
Proportion of participants with positive I-124 PET in participants who have negative I-123 SPECT 1 day In the subset of participants where the consensus read of the I-123 imaging study was negative, then the participant level detection rate for this population will be determined. The detection rate will be assessed by calculating the number of participants interpreted as having a positive I-124 PET divided by the total number of participants with a negative I-123 SPECT scan evaluated by a reader.
Trial Locations
- Locations (1)
University of California, San Francisco
🇺🇸San Francisco, California, United States