Differentiated Thyroid CancerNCT04563780
The Prognostic Value of Post Thyroidectomy 99mTCpertechnetate Thyroid Scan in Patient With Differentiated Thyroid Cancer
An observational study of Differentiated Thyroid Cancer, run by Assiut University at 1 site in Egypt.
Trial summary
The aim of this study is to evaluate the prognostic value of postoperative99mTc-pertechnetate scanning in patients with DTC. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Differentiated Thyroid Cancer
- What is being tested?
- 99mTC pertechnetate thyroid scan
- Type of treatment
- Injection or infusion, Medical device
- How many people
- 113 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Oct 2020to 31 Dec 2021
- 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 Any age
- All sexes
- Child, Adult, Older adult
Study population: all patient underwent total thyroidectomy in low and intermediate risk will done thyroid scan
Who may be able to join
- • This study will include pathologically proved DTC patients in low and intermediate risk according to ATA who presented to nuclear medicine unit during the period from 2015 until the end of the study.
Who cannot join
- • High risk patient according to ATA
- Pregnancy
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Aya Khaled Mahmoud
Asyut, 71511
Aya Khaled, 01021427102, aayahkhaled@gmail.com
Waleed Diab, assist prof, 01004242213, Drwaleedin2000@gmail.com
About this study
The aim of this study is to evaluate the prognostic value of postoperative99mTc-pertechnetate scanning in patients with DTC.
Read the detailed description
The incidence of thyroid cancer in several affluent countries has markedly increased (1). Although mortality from thyroid cancer has remained relatively low and stable or has steadily declined in these and other countries (2).
Therefore, it is still important to identify markers for prognosis prediction and decision-making before radioactive iodine therapy (RIT). Various factors have been reported to be associated with the clinical outcome of RIT. These include preablative stimulated thyroglobulin (ps- Tg), tumor size, extrathyroidal invasiveness, cervical lymph node metastasis and TSH [3,4].
99mTc pertechnetate is a radiopharmaceutical used for thyroid scintigraphy. The photon energy of 140kev is ideally suited for use with gamma camera. It has short half life of about 6-hoursand no particulate emissions. 99mTc-pertechnetate scintigraphy is a simple, economic and RIT non-interfering technique to evaluate the volume of residual thyroid tissue(RTT). The 99m Tc-pertechnetate uptake of the thyroid bed can be used as a marker of RTT. Although negative uptake doesn't indicate the absence of RTT, it could suggest a small volume. On the other hand, positive uptake can be considered as a large volume of RTT. Several studies have reported that patients with negative 99mTc-pertechnetate uptake have a much higher chance of successful ablation[5, 6].
We hypothesized that negative 99mTc-pertechnetate scintigraphy is a significant predictor for excellent response (ER) to RIT in American Thyroid Association 2015(ATA) low- and intermediate risk DTC patient according to .
- Conditions
- Differentiated Thyroid Cancer
- Being tested
- 99mTC pertechnetate thyroid scan
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
99mTC pertechnetate thyroid scanDevice
Thyroid scintigraphy was performed just before RIT. 20 min after intravenous injection 99mTc-pertechnetate, anterior images of the neck were acquired using a scintillation camera equipped with low-energy high resolution collimator. Energy discrimination was provided with a 20% window that was centered on the 140 keV peak of 99mTc .
What is being measured
The primary outcome is the main question the study is designed to answer.
The prognostic value of post thyroidectomy 99mTCpertechnetate thyroid scan in patient with differentiated thyroid cancer
The prognostic value of post thyroidectomy 99mTCpertechnetate thyroid scan in patient with differentiated thyroid cancer
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2020
- Study start1 Oct 2020
- Primary completion31 Dec 2021 (estimated)
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Differentiated 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
- Retrospective
- Enrolment
- 113 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aya Khaled Mahmoud, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04563780
- Sponsor's protocol ID
- 99mTC thyroid scan in DTC
- Status last verified
- Feb 2021
- First submitted
- 21 Sep 2020
- Last updated
- 4 Feb 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Dal Maso L, Panato C, Franceschi S, Serraino D, Buzzoni C, Busco S, Ferretti S, Torrisi A, Falcini F, Zorzi M, Cirilli C, Mazzucco W, Magoni M, Collarile P, Pannozzo F, Caiazzo AL, Russo AG, Gili A, Caldarella A, Zanetti R, Michiara M, Mangone L, Filiberti RA, Fusco M, Gasparini F, Tagliabue G, Cesaraccio R, Tumino R, Gatti L, Tisano F, Piffer S, Sini GM, Mazzoleni G, Rosso S, Fanetti AC, Vaccarella S; for AIRTUM working group. The impact of overdiagnosis on thyroid cancer epidemic in Italy,1998-2012. Eur J Cancer. 2018 May;94:6-15. doi: 10.1016/j.ejca.2018.01.083. Epub 2018 Mar 20.
PubMed 29502036Li M, Brito JP, Vaccarella S. Long-Term Declines of Thyroid Cancer Mortality: An International Age-Period-Cohort Analysis. Thyroid. 2020 Jun;30(6):838-846. doi: 10.1089/thy.2019.0684. Epub 2020 Mar 2.
PubMed 31964280Liu N, Meng Z, Jia Q, Tan J, Zhang G, Zheng W, Wang R, Li X, Hu T, Upadhyaya A, Zhou P, Wang S. Multiple-factor analysis of the first radioactive iodine therapy in post-operative patients with differentiated thyroid cancer for achieving a disease-free status. Sci Rep. 2016 Oct 10;6:34915. doi: 10.1038/srep34915.
PubMed 27721492Jung JS, Lee SM, Kim SJ, Choi J, Han SW. Prediction of the success of thyroid remnant ablation using preablative 99mTc pertechnetate scintigraphy and postablative dual 131I scintigraphy. Nucl Med Commun. 2015 Jan;36(1):38-44. doi: 10.1097/MNM.0000000000000219.
PubMed 25299469Tsai CJ, Cheng CY, Shen DH, Kuo SJ, Wang LY, Lee CH, Wang JJ, Chang MC, Huang WS. Tc-99m imaging in thyroidectomized differentiated thyroid cancer patients immediately before I-131 treatment. Nucl Med Commun. 2016 Feb;37(2):182-7. doi: 10.1097/MNM.0000000000000426.
PubMed 26626550Furuya-Kanamori L, Bell KJL, Clark J, Glasziou P, Doi SAR. Prevalence of Differentiated Thyroid Cancer in Autopsy Studies Over Six Decades: A Meta-Analysis. J Clin Oncol. 2016 Oct 20;34(30):3672-3679. doi: 10.1200/JCO.2016.67.7419.
PubMed 27601555
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Prognostic Value of Post Thyroidectomy 99mTCpertechnetate Thyroid Scan in Patient With Differentiated Thyroid Cancer
- ClinicalTrials.gov ID
- NCT04563780
- Acronym / sponsor ID
- 99mTC thyroid scan in DTC
- Conditions
- Differentiated Thyroid Cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 113 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 24 Sep 2020 (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.
The aim of this study is to evaluate the prognostic value of postoperative99mTc-pertechnetate scanning in patients with DTC.
Detailed description
The incidence of thyroid cancer in several affluent countries has markedly increased (1). Although mortality from thyroid cancer has remained relatively low and stable or has steadily declined in these and other countries (2).
Therefore, it is still important to identify markers for prognosis prediction and decision-making before radioactive iodine therapy (RIT). Various factors have been reported to be associated with the clinical outcome of RIT. These include preablative stimulated thyroglobulin (ps- Tg), tumor size, extrathyroidal invasiveness, cervical lymph node metastasis and TSH [3,4].
99mTc pertechnetate is a radiopharmaceutical used for thyroid scintigraphy. The photon energy of 140kev is ideally suited for use with gamma camera. It has short half life of about 6-hoursand no particulate emissions. 99mTc-pertechnetate scintigraphy is a simple, economic and RIT non-interfering technique to evaluate the volume of residual thyroid tissue(RTT). The 99m Tc-pertechnetate uptake of the thyroid bed can be used as a marker of RTT. Although negative uptake doesn't indicate the absence of RTT, it could suggest a small volume. On the other hand, positive uptake can be considered as a large volume of RTT. Several studies have reported that patients with negative 99mTc-pertechnetate uptake have a much higher chance of successful ablation[5, 6].
We hypothesized that negative 99mTc-pertechnetate scintigraphy is a significant predictor for excellent response (ER) to RIT in American Thyroid Association 2015(ATA) low- and intermediate risk DTC patient according to .
Study design
- Observational model
- Other
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- all patient underwent total thyroidectomy in low and intermediate risk will done thyroid scan
Key inclusion criteria (1 listed)
- • This study will include pathologically proved DTC patients in low and intermediate risk according to ATA who presented to nuclear medicine unit during the period from 2015 until the end of the study.
Key exclusion criteria (2 listed)
- • High risk patient according to ATA
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 99mTC pertechnetate thyroid scanThyroid scintigraphy was performed just before RIT. 20 min after intravenous injection 99mTc-pertechnetate, anterior images of the neck were acquired using a scintillation camera equipped with low-energy high resolution collimator. Energy discrimination was provided with a 20% window that was centered on the 140 keV peak of 99mTc . | Device | – |
Primary outcome
The prognostic value of post thyroidectomy 99mTCpertechnetate thyroid scan in patient with differentiated thyroid cancer
Time frame: baseline
The prognostic value of post thyroidectomy 99mTCpertechnetate thyroid scan in patient with differentiated thyroid cancer
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2021.
- Background: PubMed 29502036Dal Maso L, Panato C, Franceschi S, Serraino D, Buzzoni C, Busco S, Ferretti S, Torrisi A, Falcini F, Zorzi M, Cirilli C, Mazzucco W, Magoni M, Collarile P, Pannozzo F, Caiazzo AL, Russo AG, Gili A, Caldarella A, Zanetti R, Michiara M, Mangone L, Filiberti RA, Fusco M, Gasparini F, Tagliabue G, Cesaraccio R, Tumino R, Gatti L, Tisano F, Piffer S, Sini GM, Mazzoleni G, Rosso S, Fanetti AC, Vaccarella S; for AIRTUM working group. The impact of overdiagnosis on thyroid cancer epidemic in Italy,1998-2012. Eur J Cancer. 2018 May;94:6-15. doi: 10.1016/j.ejca.2018.01.083. Epub 2018 Mar 20.
- Background: PubMed 31964280Li M, Brito JP, Vaccarella S. Long-Term Declines of Thyroid Cancer Mortality: An International Age-Period-Cohort Analysis. Thyroid. 2020 Jun;30(6):838-846. doi: 10.1089/thy.2019.0684. Epub 2020 Mar 2.
- Background: PubMed 27721492Liu N, Meng Z, Jia Q, Tan J, Zhang G, Zheng W, Wang R, Li X, Hu T, Upadhyaya A, Zhou P, Wang S. Multiple-factor analysis of the first radioactive iodine therapy in post-operative patients with differentiated thyroid cancer for achieving a disease-free status. Sci Rep. 2016 Oct 10;6:34915. doi: 10.1038/srep34915.
- Background: PubMed 25299469Jung JS, Lee SM, Kim SJ, Choi J, Han SW. Prediction of the success of thyroid remnant ablation using preablative 99mTc pertechnetate scintigraphy and postablative dual 131I scintigraphy. Nucl Med Commun. 2015 Jan;36(1):38-44. doi: 10.1097/MNM.0000000000000219.
- Background: PubMed 26626550Tsai CJ, Cheng CY, Shen DH, Kuo SJ, Wang LY, Lee CH, Wang JJ, Chang MC, Huang WS. Tc-99m imaging in thyroidectomized differentiated thyroid cancer patients immediately before I-131 treatment. Nucl Med Commun. 2016 Feb;37(2):182-7. doi: 10.1097/MNM.0000000000000426.
- Background: PubMed 27601555Furuya-Kanamori L, Bell KJL, Clark J, Glasziou P, Doi SAR. Prevalence of Differentiated Thyroid Cancer in Autopsy Studies Over Six Decades: A Meta-Analysis. J Clin Oncol. 2016 Oct 20;34(30):3672-3679. doi: 10.1200/JCO.2016.67.7419.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Differentiated Thyroid Cancer, run by Assiut University at 1 site in Egypt.
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 1 inclusion and 2 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 4 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Contact Aya Khaled (01021427102, aayahkhaled@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The prognostic value of post thyroidectomy 99mTCpertechnetate thyroid scan in patient with differentiated thyroid cancer (time frame: baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04563780, which also lists 6 linked publications.
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 4 Feb 2021.