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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04563780
Other study ID # 99mTC thyroid scan in DTC
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date October 1, 2020
Est. completion date December 31, 2021

Study information

Verified date February 2021
Source Assiut University
Contact Aya Khaled
Phone 01021427102
Email aayahkhaled@gmail.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The aim of this study is to evaluate the prognostic value of postoperative99mTc-pertechnetate scanning in patients with DTC.


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 .


Recruitment information / eligibility

Status Recruiting
Enrollment 113
Est. completion date December 31, 2021
Est. primary completion date December 31, 2021
Accepts healthy volunteers
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - • 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. Exclusion Criteria: - • High risk patient according to ATA - Pregnancy

Study Design


Intervention

Device:
99mTC pertechnetate thyroid scan
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 .

Locations

Country Name City State
Egypt Aya Khaled Mahmoud Assiut

Sponsors (1)

Lead Sponsor Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

References & Publications (6)

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. — View Citation

Furuya-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. — View Citation

Jung 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. — View Citation

Li 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. — View Citation

Liu 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. — View Citation

Tsai 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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 baseline
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