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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05554302
Other study ID # 2021-KOT-003
Secondary ID
Status Recruiting
Phase Phase 2
First received
Last updated
Start date January 10, 2023
Est. completion date June 30, 2025

Study information

Verified date December 2023
Source Baptist Health South Florida
Contact Rupesh R Kotecha, M.D.
Phone 17865962000
Email rupeshk@baptisthealth.net
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study is for patients who have had surgery to remove brain metastasis and are planned to have stereotactic radiosurgery (SRS) after their brain surgery. It will be optional for patients to have a pre-surgery 18F-Fluciclovine PET/CT scan. The goal of the study is to determine whether a specific imaging agent, known as 18F-Fluciclovine, will help physicians evaluate the extent of surgery and determine if there is any visible tumor above what MRI alone can identify as well as improve the physicians' ability to detect recurring disease. This agent (18F-Fluciclovine) is investigational for the imaging of brain metastases.


Recruitment information / eligibility

Status Recruiting
Enrollment 20
Est. completion date June 30, 2025
Est. primary completion date June 30, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: 1. Age = 18 years 2. Performance status, Eastern Cooperative Oncology Group (ECOG) 0-3 3. Radiographic diagnosis of brain metastasis 4. Patient planned for surgical intervention for at least 1 metastasis 5. Patient planned for postoperative SRS Male or female patients of reproductive potential need to employ two highly effective and acceptable forms of contraception for at least 4 weeks prior to screening and agreement to use such a method during study participation and for an additional 1 week after post-treatment 18F-Fluciclovine PET/CT. Highly effective and acceptable forms of contraception are: - Male condom plus spermicide - Cap plus spermicide - Diaphragm plus spermicide - Copper T - Progesterone T - Levonorgestrel-releasing intrauterine system (e.g., Mirena®) - Implants - Hormone shot or injection - Combined pill - Mini-pill - Patch Postmenopausal people on the study (that will not need contraception) is defined as at least one of the following: - Amenorrhoeic for 1 year or more following cessation of exogenous hormonal treatments - Luteinizing hormone (LH) and follicle stimulating hormone (FSH) levels in the postmenopausal range for women under 50 - Radiation-induced oophorectomy with last menses > 1 year ago - Chemotherapy-induced menopause with >1 year interval since last menses - Surgical sterilization (bilateral oophorectomy or hysterectomy). Exclusion Criteria: 1. Prior anaphylactic reaction to 18F-Fluciclovine 2. Evidence of leptomeningeal disease 3. Prior whole-brain radiation therapy 4. Contraindication to MRI (e.g., due to safety reasons, such as presence of a pacemaker) 5. Pregnant at the expected time of 18F-fluciclovine administration 6. Expecting to be breastfeeding at the time of 18F-Fluciclovine and unwilling to stop breast-feeding for 24 hours. Temporary cessation of breastfeeding 24 hours after the time of imaging is allowed.

Study Design


Intervention

Drug:
18F-Fluciclovine
Patients will receive 5-mCi dose (+/- 20%) of 18F-Fluciclovine intravenously as a bolus injection. They will be required to fast for at least four hours prior to 18F-Fluciclovine injection. Patients will be positioned for PET/CT brain imaging and will be injected with 18F-Fluciclovine immediately prior to PET data acquisition. PET data will be collected in list mode up to 25 minutes post-injection. PET images will be reconstructed in two ways: as a standard static image of data acquired between 10 to 20 minutes post-injection, and as a dynamic series of four 5-minute frames between 5 to 25 minutes post-injection to allow for motion assessment and correction and time-dependent observations.

Locations

Country Name City State
United States Miami Cancer Institute at Baptist Health South Florida Miami Florida

Sponsors (2)

Lead Sponsor Collaborator
Baptist Health South Florida Blue Earth Diagnostics

Country where clinical trial is conducted

United States, 

References & Publications (23)

Albert NL, Weller M, Suchorska B, Galldiks N, Soffietti R, Kim MM, la Fougere C, Pope W, Law I, Arbizu J, Chamberlain MC, Vogelbaum M, Ellingson BM, Tonn JC. Response Assessment in Neuro-Oncology working group and European Association for Neuro-Oncology recommendations for the clinical use of PET imaging in gliomas. Neuro Oncol. 2016 Sep;18(9):1199-208. doi: 10.1093/neuonc/now058. Epub 2016 Apr 21. — View Citation

Choi HJ, Choi SK, Lim YJ. Radiosurgical techniques and clinical outcomes of gamma knife radiosurgery for brainstem arteriovenous malformations. J Korean Neurosurg Soc. 2012 Dec;52(6):534-40. doi: 10.3340/jkns.2012.52.6.534. Epub 2012 Dec 31. — View Citation

Doi Y, Kanagawa M, Maya Y, Tanaka A, Oka S, Nakata N, Toyama M, Matsumoto H, Shirakami Y. Evaluation of trans-1-amino-3-18F-fluorocyclobutanecarboxylic acid accumulation in low-grade glioma in chemically induced rat models: PET and autoradiography compared with morphological images and histopathological findings. Nucl Med Biol. 2015 Aug;42(8):664-72. doi: 10.1016/j.nucmedbio.2015.04.008. Epub 2015 May 7. — View Citation

Galldiks N, Langen KJ. Amino acid PET in neuro-oncology: applications in the clinic. Expert Rev Anticancer Ther. 2017 May;17(5):395-397. doi: 10.1080/14737140.2017.1302799. Epub 2017 Mar 11. No abstract available. — View Citation

Gondi V, Bradley K, Mehta M, Howard A, Khuntia D, Ritter M, Tome W. Impact of hybrid fluorodeoxyglucose positron-emission tomography/computed tomography on radiotherapy planning in esophageal and non-small-cell lung cancer. Int J Radiat Oncol Biol Phys. 2007 Jan 1;67(1):187-95. doi: 10.1016/j.ijrobp.2006.09.033. — View Citation

Gui C, Moore J, Grimm J, Kleinberg L, McNutt T, Shen C, Chen L, Bettegowda C, Lim M, Redmond KJ. Local recurrence patterns after postoperative stereotactic radiation surgery to resected brain metastases: A quantitative analysis to guide target delineation. Pract Radiat Oncol. 2018 Nov-Dec;8(6):388-396. doi: 10.1016/j.prro.2018.04.010. Epub 2018 Apr 26. — View Citation

Jhaveri J, Chowdhary M, Zhang X, Press RH, Switchenko JM, Ferris MJ, Morgan TM, Roper J, Dhabaan A, Elder E, Eaton BR, Olson JJ, Curran WJ, Shu HG, Crocker IR, Patel KR. Does size matter? Investigating the optimal planning target volume margin for postoperative stereotactic radiosurgery to resected brain metastases. J Neurosurg. 2018 Apr 20;130(3):797-803. doi: 10.3171/2017.9.JNS171735. — View Citation

Kondo A, Ishii H, Aoki S, Suzuki M, Nagasawa H, Kubota K, Minamimoto R, Arakawa A, Tominaga M, Arai H. Phase IIa clinical study of [18F]fluciclovine: efficacy and safety of a new PET tracer for brain tumors. Ann Nucl Med. 2016 Nov;30(9):608-618. doi: 10.1007/s12149-016-1102-y. Epub 2016 Jul 14. — View Citation

Kotecha R, Ahluwalia MS, Siomin V, McDermott MW. Surgery, Stereotactic Radiosurgery, and Systemic Therapy in the Management of Operable Brain Metastasis. Neurol Clin. 2022 May;40(2):421-436. doi: 10.1016/j.ncl.2021.11.002. Epub 2022 Mar 31. — View Citation

Kotecha R, Gondi V, Ahluwalia MS, Brastianos PK, Mehta MP. Recent advances in managing brain metastasis. F1000Res. 2018 Nov 9;7:F1000 Faculty Rev-1772. doi: 10.12688/f1000research.15903.1. eCollection 2018. — View Citation

Oka S, Okudaira H, Ono M, Schuster DM, Goodman MM, Kawai K, Shirakami Y. Differences in transport mechanisms of trans-1-amino-3-[18F]fluorocyclobutanecarboxylic acid in inflammation, prostate cancer, and glioma cells: comparison with L-[methyl-11C]methionine and 2-deoxy-2-[18F]fluoro-D-glucose. Mol Imaging Biol. 2014 Jun;16(3):322-9. doi: 10.1007/s11307-013-0693-0. — View Citation

Oka S, Okudaira H, Yoshida Y, Schuster DM, Goodman MM, Shirakami Y. Transport mechanisms of trans-1-amino-3-fluoro[1-(14)C]cyclobutanecarboxylic acid in prostate cancer cells. Nucl Med Biol. 2012 Jan;39(1):109-19. doi: 10.1016/j.nucmedbio.2011.06.008. Epub 2011 Sep 29. — View Citation

Okudaira H, Shikano N, Nishii R, Miyagi T, Yoshimoto M, Kobayashi M, Ohe K, Nakanishi T, Tamai I, Namiki M, Kawai K. Putative transport mechanism and intracellular fate of trans-1-amino-3-18F-fluorocyclobutanecarboxylic acid in human prostate cancer. J Nucl Med. 2011 May;52(5):822-9. doi: 10.2967/jnumed.110.086074. — View Citation

Ono M, Oka S, Okudaira H, Schuster DM, Goodman MM, Kawai K, Shirakami Y. Comparative evaluation of transport mechanisms of trans-1-amino-3-[(1)(8)F]fluorocyclobutanecarboxylic acid and L-[methyl-(1)(1)C]methionine in human glioma cell lines. Brain Res. 2013 Oct 16;1535:24-37. doi: 10.1016/j.brainres.2013.08.037. Epub 2013 Aug 27. — View Citation

Parent EE, Benayoun M, Ibeanu I, Olson JJ, Hadjipanayis CG, Brat DJ, Adhikarla V, Nye J, Schuster DM, Goodman MM. [18F]Fluciclovine PET discrimination between high- and low-grade gliomas. EJNMMI Res. 2018 Jul 25;8(1):67. doi: 10.1186/s13550-018-0415-3. — View Citation

Parent EE, Patel D, Nye JA, Li Z, Olson JJ, Schuster DM, Goodman MM. [18F]-Fluciclovine PET discrimination of recurrent intracranial metastatic disease from radiation necrosis. EJNMMI Res. 2020 Dec 7;10(1):148. doi: 10.1186/s13550-020-00739-6. — View Citation

Sasajima T, Ono T, Shimada N, Doi Y, Oka S, Kanagawa M, Baden A, Mizoi K. Trans-1-amino-3-18F-fluorocyclobutanecarboxylic acid (anti-18F-FACBC) is a feasible alternative to 11C-methyl-L-methionine and magnetic resonance imaging for monitoring treatment response in gliomas. Nucl Med Biol. 2013 Aug;40(6):808-15. doi: 10.1016/j.nucmedbio.2013.04.007. Epub 2013 May 21. — View Citation

Shi S, Sandhu N, Jin M, Wang E, Liu E, Jaoude JA, Schofield K, Zhang C, Gibbs IC, Hancock SL, Chang SD, Li G, Gephart MH, Pollom EL, Soltys SG. Stereotactic Radiosurgery for Resected Brain Metastases: Does the Surgical Corridor Need to be Targeted? Pract Radiat Oncol. 2020 Sep-Oct;10(5):e363-e371. doi: 10.1016/j.prro.2020.04.009. Epub 2020 May 16. — View Citation

Soliman H, Ruschin M, Angelov L, Brown PD, Chiang VLS, Kirkpatrick JP, Lo SS, Mahajan A, Oh KS, Sheehan JP, Soltys SG, Sahgal A. Consensus Contouring Guidelines for Postoperative Completely Resected Cavity Stereotactic Radiosurgery for Brain Metastases. Int J Radiat Oncol Biol Phys. 2018 Feb 1;100(2):436-442. doi: 10.1016/j.ijrobp.2017.09.047. Epub 2017 Oct 4. — View Citation

Soltys JS, Wilson SE. Directional sensitivity of velocity sense in the lumbar spine. J Appl Biomech. 2008 Aug;24(3):244-51. doi: 10.1123/jab.24.3.244. — View Citation

Tsuyuguchi N, Terakawa Y, Uda T, Nakajo K, Kanemura Y. Diagnosis of Brain Tumors Using Amino Acid Transport PET Imaging with 18F-fluciclovine: A Comparative Study with L-methyl-11C-methionine PET Imaging. Asia Ocean J Nucl Med Biol. 2017 Spring;5(2):85-94. doi: 10.22038/aojnmb.2017.8843. — View Citation

Wakabayashi T, Hirose Y, Miyake K, Arakawa Y, Kagawa N, Nariai T, Narita Y, Nishikawa R, Tsuyuguchi N, Fukami T, Sasaki H, Sasayama T, Kondo A, Iuchi T, Matsuda H, Kubota K, Minamimoto R, Terauchi T, Nakazato Y, Kubomura K, Wada M. Determining the extent of tumor resection at surgical planning with 18F-fluciclovine PET/CT in patients with suspected glioma: multicenter phase III trials. Ann Nucl Med. 2021 Dec;35(12):1279-1292. doi: 10.1007/s12149-021-01670-z. Epub 2021 Aug 18. — View Citation

Wakabayashi T, Iuchi T, Tsuyuguchi N, Nishikawa R, Arakawa Y, Sasayama T, Miyake K, Nariai T, Narita Y, Hashimoto N, Okuda O, Matsuda H, Kubota K, Ito K, Nakazato Y, Kubomura K. Diagnostic Performance and Safety of Positron Emission Tomography Using 18F-Fluciclovine in Patients with Clinically Suspected High- or Low-grade Gliomas: A Multicenter Phase IIb Trial. Asia Ocean J Nucl Med Biol. 2017 Winter;5(1):10-21. doi: 10.22038/aojnmb.2016.7869. — View Citation

* Note: There are 23 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary Change in conformality index of tumor target volume delineation The tumor target volume (post-operative cavity and any residual or recurrent disease) will be delineated by post-operative MRI only. A second target volume will be generated using the 18F-Fluciclovine PET-defined volume. The conformality index is calculated by comparing the PET-defined tumor volume with MRI-defined tumor volume. Non-overlapping and overlapping regions regions of PET tumor volume and MRI tumor volume will be used to calculate conformality indices. 3 weeks, 6 and 12 months
Primary Change in PET scan standardized uptake value (SUV) parameters The standardized uptake value (SUV) parameters of SUVpeak, SUVmean, and SUVmax will be measured to determine if they correlate tumor volume and can predict risk of recurrence. 3 weeks, 6 and 12 months
Secondary Time to local failure Each lesion will be followed from pre-treatment PET to local failure or re-retreatment; death; 12 months from pre-treatment PET; lost-to follow-up, discontinuation, or withdrawal; or end of study. In the event that a patient has more than one study eligible lesion, the patient will discontinue follow up after all lesions progress, or will be censored as above. Death will be treated as a competing event. 1 year
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