Thyroid CancerNCT04128631
Thyroid Cancer and (FDG)PET/CT Scan
An observational study of Thyroid Cancer, run by Assiut University.
Trial summary
Background and Rational (Introduction) Differentiated thyroid carcinoma (DTC) have favorable prognosis. Overall 10-year survival is 93% for papillary carcinoma, and 85% for follicular carcinoma(1). Read more about this study
- Who is it for?
- Ages 10 to 80 years
- Conditions the study is for
- Thyroid Cancer
- How many people
- 35 participants
- Where
- No sites listed yet
- Study dates
- 30 Oct 2019to 1 Dec 2020
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: This study will include thyroid cancer patients of wide age ranges, who underwent total thyroidectomy with negative radioactive iodine whole body scan (I-WBS) and elevated stimulated thyroglobulin (sTg) or thyroglobulin antibody (TgAb) levels.
Who may be able to join
- · This study will include thyroid cancer patients of wide age ranges, who underwent total thyroidectomy with negative radioactive iodine whole body scan (I-WBS) and elevated stimulated thyroglobulin (sTg) or thyroglobulin antibody (TgAb) levels.
- Patients able to sleep in a fixed position for 20 minutes.
Who cannot join
- Patients unable to sit calm without movement during imaging.
- Severely ill patients.
- Patients' blood glucose \> 11.1 mmol/L (200 mg/dL) measured by glucometer immediately prior to scan.
- Pregnancy
About this study
Official title: Role of of F-18-fluoro-deoxy-glucose (FDG) PET/CT in Thyroid Cancer Patients With Negative I-131whole Body Scan and Elevated Thyroglobulin Level or Positive Anti Thyroglobulin Antibodies
Background and Rational
(Introduction)
Read more
Differentiated thyroid carcinoma (DTC) have favorable prognosis. Overall 10-year survival is 93% for papillary carcinoma, and 85% for follicular carcinoma(1). After total thyroidectomy followed by radioiodine remnant ablation, DTC patients are screened for recurrence by measuring the levels of both Tg and TgAb and I-131 whole body scan (WBS) in the follow-up (2) It is reported that elevated TgAb may indicate the recurrent and/or metastatic disease and can be used as an alternative of the tumor marker for DTC . The I-131 WBS has high specificity to detect recurrence (50 to 60% in papillary thyroid carcinoma and 64 to 67% in follicular thyroid carcinoma) (3,4). The I-131WBS showed negative finding in 10 to 15% of patients with detectable serum Tg levels(5). Two factors may account for discrepancy between serum Tg and I-131 WBS . First, the tumor size might be too small to be detected by WBS. Second, the tumor cell may lose the ability to trap radioiodine while still able to secret Tg(6,7). It becomes necessary to investigate with other modalities to identify possible residual disease to initiate the appropriate treatment. (8)
Positron emission tomography with 2-deoxy-2-[fluorine-18]fluoro- D-glucose integrated with computed tomography (18F-FDG PET/CT) has emerged as a powerful imaging tool for the detection of various cancers. (9)
The combined acquisition of PET and CT has synergistic advantages over PET or CT alone and minimizes their individual limitations. (10)
It is a valuable tool for staging and re staging of some tumors and has an important role in the detection of recurrence in asymptomatic patients with rising tumor marker levels and patients with negative or equivocal findings on conventional imaging techniques.(11)
Aim of the study
The aim of this study was to evaluate the diagnostic accuracy of (PET/CT) in patients with suspected thyroid cancer recurrence or metastasis , with differentiated thyroid cancer (DTC) patients who show elevated serum thyroglobulin (Tg) or antithyroglobulin antibody (TgAb) level with negative radioiodine whole body scan (I-WBS).
Read the detailed description
Design and Methodology
Study design:-
It's a prospective study for the group of patients who will do F-18FDG PET/CT scan after negative whole body scan with elevated serum thyroglobulin Antibody or Thyroglobulin levels.
Pre-study investigations:-
- All patients at this study should have histopathological evidence of DTC
- serum TSH level
- serum TG \& antiTG antibodies levels
- radioactiveiodine whole body scan (I-WBS)
- Neck ultrasound
- Blood glucose level
Radioisotopes:
Iodine-131 (I-131) is an important radioisotope of iodine as a major product of Uranium fission. It is a β-emitting radionuclide with a maximum energy of 606 keV and an average energy of 191 keV. Average range of β-particles in tissue is 0.8 mm and has a principal γ-ray of 364 keV. It has a radioactive decay half-life of about eight days. Only well-differentiated thyroid cancer cells concentrate radioiodine to a significant degree.
F-18-fluoro-2-deoxyglucose (FDG) is a positron emitting radiotracer that is transported intracellularly and phosphorylated by hexokinase to FDG-6-PO4 through the same cellular membrane transport pathways as glucose. Unlike glucose, however, FDG-6-PO4 is subsequently trapped intracellularly due to lack of further metabolism from insufficient amounts of glucose phosphatase. After intravenous administration, this substrate accumulates in tumors during the uptake phase, and whole body imaging can then be performed to identify regions of high glycolytic activity. and can be used to characterize and localize many types of tumors as well as determining stage and sites of recurrent disease.
Patient preparation
- Patients fasted for at least 6 hours before F-18FDG PET/CT imaging with the exception of water intake.
- The blood glucose level was measured before tracer injection. The blood glucose levels of all patients should be less than 150 mg/dL .
- An intravenous catheter was placed for radiopharmaceutical administration,
- After tracer injection, the patients rested on a comfortable chair during the 18F-FDG uptake period
F-18FDG PET/CT Imaging
PET/CT was initiated (45-60) min after injection of the F-18-FDG, Each patient received 400-610 MBq (11-16.5 mCi) of 18F-FDG intravenously. CT was performed before acquisition of the PET data in a single step with the patients supine. First, a scout scan was obtained to determine the axial range of the study. The scanning parameters for whole-body CT craniocaudal scanning are 130 kV, 80-120 mAs, 5-mm collimation, and a pitch of 1.6. During the scan, patients have to maintain shallow respiration.
The subsequent 3-dimensional PET data acquisition included 4-6 bed positions, (4 min per bed position) over the same axial extent. The PET acquisition included a dead time correction and online delayed coincidence subtraction to correct for random coincidences. Rescaled CT images were used to produce attenuation correction values for the PET emission reconstruction.
- Conditions
- Thyroid Cancer
- Medical subject headings
- Thyroid Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| PET/CT | group of patients will do F-18FDG PET/CT scan after negative whole body scan with elevated serum thyroglobulin Antibody or Thyroglobulin levels. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence and metastasis
Detection of recurrence or metastasis in patient with negative radioactive iodine scan and elevated stimulated thyroglobulin (sTg) or thyroglobulin antibody (TgAb) levels.By progressively increase level of serum Thyroglobulin or thyroglobulin antibodies
Measured: six months
Secondary outcomes (1)
Improve survival rate
initiate appropriate treatment to those patients improve survival and quality of life
Measured: six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2019
- Study start30 Oct 2019 (estimated)
- Primary completion1 Sep 2020 (estimated)
- Study completion1 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thyroid CancerStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 35 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, RMFarghali, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04128631
- Sponsor's protocol ID
- FDGPET
- Status last verified
- Sep 2019
- First submitted
- 26 Sep 2019
- Last updated
- 16 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of of F-18-fluoro-deoxy-glucose (FDG) PET/CT in Thyroid Cancer Patients With Negative I-131whole Body Scan and Elevated Thyroglobulin Level or Positive Anti Thyroglobulin Antibodies
- ClinicalTrials.gov ID
- NCT04128631
- Acronym / sponsor ID
- FDGPET
- Conditions
- Thyroid Cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 30 Oct 2019 (estimated)
- Primary completion
- 1 Sep 2020 (estimated)
- Study completion
- 1 Dec 2020 (estimated)
- First posted
- 16 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Background and Rational
(Introduction)
Differentiated thyroid carcinoma (DTC) have favorable prognosis. Overall 10-year survival is 93% for papillary carcinoma, and 85% for follicular carcinoma(1). After total thyroidectomy followed by radioiodine remnant ablation, DTC patients are screened for recurrence by measuring the levels of both Tg and TgAb and I-131 whole body scan (WBS) in the follow-up (2) It is reported that elevated TgAb may indicate the recurrent and/or metastatic disease and can be used as an alternative of the tumor marker for DTC . The I-131 WBS has high specificity to detect recurrence (50 to 60% in papillary thyroid carcinoma and 64 to 67% in follicular thyroid carcinoma) (3,4). The I-131WBS showed negative finding in 10 to 15% of patients with detectable serum Tg levels(5). Two factors may account for discrepancy between serum Tg and I-131 WBS . First, the tumor size might be too small to be detected by WBS. Second, the tumor cell may lose the ability to trap radioiodine while still able to secret Tg(6,7). It becomes necessary to investigate with other modalities to identify possible residual disease to initiate the appropriate treatment. (8)
Positron emission tomography with 2-deoxy-2-[fluorine-18]fluoro- D-glucose integrated with computed tomography (18F-FDG PET/CT) has emerged as a powerful imaging tool for the detection of various cancers. (9)
The combined acquisition of PET and CT has synergistic advantages over PET or CT alone and minimizes their individual limitations. (10)
It is a valuable tool for staging and re staging of some tumors and has an important role in the detection of recurrence in asymptomatic patients with rising tumor marker levels and patients with negative or equivocal findings on conventional imaging techniques.(11)
Aim of the study
The aim of this study was to evaluate the diagnostic accuracy of (PET/CT) in patients with suspected thyroid cancer recurrence or metastasis , with differentiated thyroid cancer (DTC) patients who show elevated serum thyroglobulin (Tg) or antithyroglobulin antibody (TgAb) level with negative radioiodine whole body scan (I-WBS).
Detailed description
Design and Methodology
Study design:-
It's a prospective study for the group of patients who will do F-18FDG PET/CT scan after negative whole body scan with elevated serum thyroglobulin Antibody or Thyroglobulin levels.
Pre-study investigations:-
- All patients at this study should have histopathological evidence of DTC
- serum TSH level
- serum TG \& antiTG antibodies levels
- radioactiveiodine whole body scan (I-WBS)
- Neck ultrasound
- Blood glucose level
Radioisotopes:
Iodine-131 (I-131) is an important radioisotope of iodine as a major product of Uranium fission. It is a β-emitting radionuclide with a maximum energy of 606 keV and an average energy of 191 keV. Average range of β-particles in tissue is 0.8 mm and has a principal γ-ray of 364 keV. It has a radioactive decay half-life of about eight days. Only well-differentiated thyroid cancer cells concentrate radioiodine to a significant degree.
F-18-fluoro-2-deoxyglucose (FDG) is a positron emitting radiotracer that is transported intracellularly and phosphorylated by hexokinase to FDG-6-PO4 through the same cellular membrane transport pathways as glucose. Unlike glucose, however, FDG-6-PO4 is subsequently trapped intracellularly due to lack of further metabolism from insufficient amounts of glucose phosphatase. After intravenous administration, this substrate accumulates in tumors during the uptake phase, and whole body imaging can then be performed to identify regions of high glycolytic activity. and can be used to characterize and localize many types of tumors as well as determining stage and sites of recurrent disease.
Patient preparation
- Patients fasted for at least 6 hours before F-18FDG PET/CT imaging with the exception of water intake.
- The blood glucose level was measured before tracer injection. The blood glucose levels of all patients should be less than 150 mg/dL .
- An intravenous catheter was placed for radiopharmaceutical administration,
- After tracer injection, the patients rested on a comfortable chair during the 18F-FDG uptake period
F-18FDG PET/CT Imaging
PET/CT was initiated (45-60) min after injection of the F-18-FDG, Each patient received 400-610 MBq (11-16.5 mCi) of 18F-FDG intravenously. CT was performed before acquisition of the PET data in a single step with the patients supine. First, a scout scan was obtained to determine the axial range of the study. The scanning parameters for whole-body CT craniocaudal scanning are 130 kV, 80-120 mAs, 5-mm collimation, and a pitch of 1.6. During the scan, patients have to maintain shallow respiration.
The subsequent 3-dimensional PET data acquisition included 4-6 bed positions, (4 min per bed position) over the same axial extent. The PET acquisition included a dead time correction and online delayed coincidence subtraction to correct for random coincidences. Rescaled CT images were used to produce attenuation correction values for the PET emission reconstruction.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PET/CT | – | –group of patients will do F-18FDG PET/CT scan after negative whole body scan with elevated serum thyroglobulin Antibody or Thyroglobulin levels. |
Who may qualify
- Ages
- 10 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- This study will include thyroid cancer patients of wide age ranges, who underwent total thyroidectomy with negative radioactive iodine whole body scan (I-WBS) and elevated stimulated thyroglobulin (sTg) or thyroglobulin antibody (TgAb) levels.
Key inclusion criteria (2 listed)
- · This study will include thyroid cancer patients of wide age ranges, who underwent total thyroidectomy with negative radioactive iodine whole body scan (I-WBS) and elevated stimulated thyroglobulin (sTg) or thyroglobulin antibody (TgAb) levels.
Key exclusion criteria (4 listed)
- Patients unable to sit calm without movement during imaging.
- Severely ill patients.
- Patients' blood glucose \> 11.1 mmol/L (200 mg/dL) measured by glucometer immediately prior to scan.
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Recurrence and metastasis
Time frame: six months
Detection of recurrence or metastasis in patient with negative radioactive iodine scan and elevated stimulated thyroglobulin (sTg) or thyroglobulin antibody (TgAb) levels.By progressively increase level of serum Thyroglobulin or thyroglobulin antibodies
1 secondary outcome
Improve survival rate
Time frame: six months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Thyroid Cancer, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrence and metastasis (time frame: six months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2019.