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Diagnostic accuracy and clinical value of [68Ga]Ga-FAPI-46 PET/CT for staging patients with ovarian cancer: study protocol for a prospective clinical trial.

التفاصيل البيبلوغرافية
العنوان: Diagnostic accuracy and clinical value of [68Ga]Ga-FAPI-46 PET/CT for staging patients with ovarian cancer: study protocol for a prospective clinical trial.
المؤلفون: Bentestuen M; Department of Nuclear Medicine and Clinical Cancer Research Center, Aalborg University Hospital, Hobrovej 18- 22, Aalborg, DK-9000, Denmark. m.bentestuen@rn.dk.; Department of Clinical Medicine, Aalborg University, Sdr. Skovvej 11, Aalborg, DK-9000, Denmark. m.bentestuen@rn.dk., Ladekarl M; Department of Oncology and Clinical Cancer Research Center, Aalborg University Hospital, Hobrovej 18-22, Aalborg, DK- 9000, Denmark.; Department of Clinical Medicine, Aalborg University, Sdr. Skovvej 11, Aalborg, DK-9000, Denmark., Knudsen A; Department of Gynecology and Obstetrics, Aalborg University Hospital, Reberbansgade 15, Aalborg, DK-9000, Denmark.; Department of Clinical Medicine, Aalborg University, Sdr. Skovvej 11, Aalborg, DK-9000, Denmark., Zacho HD; Department of Nuclear Medicine and Clinical Cancer Research Center, Aalborg University Hospital, Hobrovej 18- 22, Aalborg, DK-9000, Denmark.; Department of Clinical Medicine, Aalborg University, Sdr. Skovvej 11, Aalborg, DK-9000, Denmark.
المصدر: BMC cancer [BMC Cancer] 2024 Jun 07; Vol. 24 (1), pp. 699. Date of Electronic Publication: 2024 Jun 07.
نوع المنشور: Journal Article; Clinical Trial Protocol
اللغة: English
بيانات الدورية: Publisher: BioMed Central Country of Publication: England NLM ID: 100967800 Publication Model: Electronic Cited Medium: Internet ISSN: 1471-2407 (Electronic) Linking ISSN: 14712407 NLM ISO Abbreviation: BMC Cancer Subsets: MEDLINE
أسماء مطبوعة: Original Publication: London : BioMed Central, [2001-
مواضيع طبية MeSH: Fluorodeoxyglucose F18* , Gallium Radioisotopes* , Neoplasm Staging* , Ovarian Neoplasms*/diagnostic imaging , Ovarian Neoplasms*/pathology , Ovarian Neoplasms*/drug therapy , Positron Emission Tomography Computed Tomography*/methods, Adult ; Aged ; Female ; Humans ; Middle Aged ; Prospective Studies ; Quinolines ; Radiopharmaceuticals ; Clinical Trials as Topic
مستخلص: Background: [ 18 F]Fluorodeoxyglucose ([ 18 F]FDG) positron emission tomography (PET) is recommended during diagnostic work-up for ovarian cancer; however, [ 18 F]FDG PET has several inherent limitations. The novel oncologic PET-tracer fibroblast activation protein inhibitor (FAPI) has demonstrated promising results in multiple cancer types, including ovarian cancer, and could overcome the limitations of [ 18 F]FDG PET; however, high-quality clinical studies are lacking. The primary objective of the present study is to compare the diagnostic accuracy of [ 68 Ga]Ga-FAPI-46 PET/CT and [ 18 F]FDG PET/CT in ovarian cancer patients and to investigate how this potential difference impacts staging and patient management.
Methods and Design: Fifty consecutive ovarian cancer patients will be recruited from Aalborg University Hospital, Denmark. This study will be a single-center, prospective, exploratory clinical trial that adheres to the standards for reporting diagnostic accuracy studies (STARD). This study will be conducted under continuous Good Clinical Practice monitoring. The eligibility criteria for patients are as follows: (1) biopsy verified newly diagnosed ovarian cancer or a high risk of ovarian cancer and referred for primary staging with [ 18 F]FDG PET/CT; and (2) resectable disease, i.e., candidate for primary debulking surgery or neoadjuvant chemotherapy followed by interval debulking surgery. All recruited study subjects will undergo [ 68 Ga]Ga-FAPI-46 PET/CT at primary staging, before primary debulking surgery or neoadjuvant chemotherapy (Group A + B), in addition to conventional imaging (including [ 18 F]FDG PET/CT). Study subjects in Group B will undergo an additional [ 68 Ga]Ga-FAPI-46 PET/CT following neoadjuvant chemotherapy prior to interval debulking surgery. The results of the study-related [ 68 Ga]Ga-FAPI-46 PET/CTs will be blinded, and treatment allocation will be based on common clinical practice in accordance with current guidelines. The histopathology of surgical specimens will serve as a reference standard. A recruitment period of 2 years is estimated; the trial is currently recruiting.
Discussion: To our knowledge, this trial represents the largest, most extensive, and most meticulous prospective FAPI PET study conducted in patients with ovarian cancer thus far. This study aims to obtain a reliable estimation of the diagnostic accuracy of [ 68 Ga]Ga-FAPI-46 PET/CT, shed light on the clinical importance of [ 68 Ga]Ga-FAPI-46 PET/CT, and examine the potential applicability of [ 68 Ga]Ga-FAPI-46 PET/CT for evaluating chemotherapy response.
Trial Registration: clinicaltrials.gov: NCT05903807, 2nd June 2023; and euclinicaltrials.eu EU CT Number: 2023-505938-98-00, authorized 11th September 2023.
(© 2024. The Author(s).)
References: J Nucl Med. 2018 Sep;59(9):1415-1422. (PMID: 29626119)
Cochrane Database Syst Rev. 2011 Aug 10;(8):CD007565. (PMID: 21833960)
AJR Am J Roentgenol. 2016 Jun;206(6):1351-60. (PMID: 27042752)
Eur J Nucl Med Mol Imaging. 2021 Jan;48(1):73-86. (PMID: 32588089)
J Ovarian Res. 2020 Oct 27;13(1):128. (PMID: 33109236)
J Gynecol Oncol. 2018 Nov;29(6):e98. (PMID: 30207106)
CA Cancer J Clin. 2017 Mar;67(2):93-99. (PMID: 28094848)
J BUON. 2019 Nov-Dec;24(6):2333-2340. (PMID: 31983103)
Cancer Lett. 2011 Apr 1;303(1):47-55. (PMID: 21310528)
Radiology. 2002 Jun;223(3):780-8. (PMID: 12034950)
J Nucl Med. 2022 Dec;63(12):1786-1792. (PMID: 36109182)
Semin Nucl Med. 2023 Sep;53(5):694-705. (PMID: 36813670)
Int J Gynecol Cancer. 2019 May 2;:. (PMID: 31048403)
J Clin Oncol. 2011 Jun 1;29(16):2253-8. (PMID: 21537035)
Ann ICRP. 2007;37(2-4):1-332. (PMID: 18082557)
Oncol Lett. 2015 Jul;10(1):34-42. (PMID: 26170973)
J Nucl Med. 2023 May;64(5):711-716. (PMID: 36581374)
Int J Gynecol Cancer. 2014 Mar;24(3):454-60. (PMID: 24463640)
J Nucl Med. 2018 Sep;59(9):1423-1429. (PMID: 29626120)
Int J Gynecol Cancer. 2012 Sep;22(7):1163-9. (PMID: 22810969)
PET Clin. 2023 Jul;18(3):419-428. (PMID: 37030981)
Int J Gynecol Cancer. 2021 Jul;31(7):961-982. (PMID: 34112736)
Ann Nucl Med. 2009 Feb;23(2):107-12. (PMID: 19225932)
Proc Natl Acad Sci U S A. 1990 Sep;87(18):7235-9. (PMID: 2402505)
Eur J Nucl Med Mol Imaging. 2008 Oct;35(10):1912-20. (PMID: 18682935)
Gynecol Oncol. 2007 Apr;105(1):145-9. (PMID: 17229460)
Semin Nucl Med. 2024 May;54(3):345-355. (PMID: 38052711)
Eur J Nucl Med Mol Imaging. 2023 Apr;50(5):1521-1531. (PMID: 36624168)
Br J Radiol. 2023 Feb;96(1142):20220463. (PMID: 35776566)
Gynecol Oncol. 2008 Feb;108(2):265-70. (PMID: 18055006)
Eur J Nucl Med Mol Imaging. 2021 Sep;48(10):3286-3302. (PMID: 34215923)
Allergy. 2009 Aug;64(8):1109-16. (PMID: 19489757)
Eur J Nucl Med Mol Imaging. 2023 Jul;50(9):2885-2898. (PMID: 37093313)
Eur J Nucl Med Mol Imaging. 2021 Dec;48(13):4377-4385. (PMID: 34137945)
Cochrane Database Syst Rev. 2018 Oct 08;10:CD012567. (PMID: 30298516)
Eur Radiol. 2020 Jun;30(6):3101-3112. (PMID: 32065287)
J Natl Compr Canc Netw. 2021 Feb 02;19(2):191-226. (PMID: 33545690)
Nucl Med Commun. 2007 Aug;28(8):589-95. (PMID: 17625380)
Semin Nucl Med. 2021 Nov;51(6):593-610. (PMID: 34253332)
Eur J Nucl Med Mol Imaging. 2021 Nov;48(12):4089-4100. (PMID: 34050777)
Chin Med J (Engl). 2007 Apr 20;120(8):663-8. (PMID: 17517181)
J Nucl Med. 2020 Aug;61(8):1171-1177. (PMID: 31836685)
Gynecol Oncol. 2014 Sep;134(3):455-61. (PMID: 25019568)
Oncol Rep. 2007 Aug;18(2):361-7. (PMID: 17611657)
Cancer Metastasis Rev. 2020 Sep;39(3):783-803. (PMID: 32601975)
Front Oncol. 2019 Aug 06;9:639. (PMID: 31448220)
Br J Radiol. 2018 Jan;91(1081):20170519. (PMID: 29099613)
Clin Nucl Med. 2021 Nov 1;46(11):906-907. (PMID: 34238809)
Int J Gynecol Cancer. 2015 Mar;25(3):407-15. (PMID: 25695545)
Eur J Nucl Med Mol Imaging. 2023 Nov;50(13):4064-4076. (PMID: 37526694)
Front Med (Lausanne). 2021 Oct 04;8:748683. (PMID: 34671627)
Am J Obstet Gynecol. 2016 Apr;214(4):424-437. (PMID: 26800772)
Nucl Med Commun. 2023 Mar 1;44(3):194-203. (PMID: 36472415)
Eur J Nucl Med Mol Imaging. 2021 Jun;48(6):1944-1955. (PMID: 33415432)
Cancers (Basel). 2023 Mar 22;15(6):. (PMID: 36980790)
PET Clin. 2018 Apr;13(2):249-268. (PMID: 29482753)
Int J Gynaecol Obstet. 2008 Aug;102(2):124-7. (PMID: 18423470)
Hum Reprod Update. 2014 May-Jun;20(3):449-62. (PMID: 24327552)
Eur J Nucl Med Mol Imaging. 2015 Feb;42(2):328-54. (PMID: 25452219)
BMJ. 2015 Oct 28;351:h5527. (PMID: 26511519)
فهرسة مساهمة: Keywords: FAPI; Fibroblast activation protein inhibitor; Ovarian cancer; PET; Positron emission tomography; [68Ga]Ga-FAPI-46
سلسلة جزيئية: ClinicalTrials.gov NCT05903807
المشرفين على المادة: 0 (68Ga-FAPI)
0Z5B2CJX4D (Fluorodeoxyglucose F18)
0 (Gallium Radioisotopes)
0 (Quinolines)
0 (Radiopharmaceuticals)
تواريخ الأحداث: Date Created: 20240607 Date Completed: 20240607 Latest Revision: 20240722
رمز التحديث: 20240723
مُعرف محوري في PubMed: PMC11157941
DOI: 10.1186/s12885-024-12461-w
PMID: 38849741
قاعدة البيانات: MEDLINE
الوصف
تدمد:1471-2407
DOI:10.1186/s12885-024-12461-w