CONCORDANT: Characterization of 18F-Fluciclovine PET Amino Acid Radiotracer in Resected Brain Metastasis
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 2 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: PET/CT, MRI All patients will obtain an 18F-Fluciclovine PET/CT scan in addition to the planning MRI at the time of SRS treatment (approximately 2-4 weeks after resection). The value of 18F-Fluciclovine in addition to structural information from the MRI will be analyzed. Patients will continue to undergo 18F-Fluciclovine in addition to MRI during routine follow-up to determine the ability of 18F-Fluciclovine PET/CT to identify areas at risk for marginal failure, monitor resection beds for tumor control, identify patients at risk for disease recurrence, and detect patterns of failure. |
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.
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Outcome Measures
Primary Outcome Measures
- Change in conformality index of tumor target volume delineation [3 weeks, 6 and 12 months]
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.
- Change in PET scan standardized uptake value (SUV) parameters [3 weeks, 6 and 12 months]
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.
Secondary Outcome Measures
- Time to local failure [1 year]
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.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Age ≥ 18 years
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Performance status, Eastern Cooperative Oncology Group (ECOG) 0-3
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Radiographic diagnosis of brain metastasis
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Patient planned for surgical intervention for at least 1 metastasis
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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:
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Male condom plus spermicide
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Cap plus spermicide
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Diaphragm plus spermicide
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Copper T
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Progesterone T
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Levonorgestrel-releasing intrauterine system (e.g., Mirena®)
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Implants
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Hormone shot or injection
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Combined pill
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Mini-pill
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Patch
Postmenopausal people on the study (that will not need contraception) is defined as at least one of the following:
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Amenorrhoeic for 1 year or more following cessation of exogenous hormonal treatments
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Luteinizing hormone (LH) and follicle stimulating hormone (FSH) levels in the postmenopausal range for women under 50
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Radiation-induced oophorectomy with last menses > 1 year ago
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Chemotherapy-induced menopause with >1 year interval since last menses
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Surgical sterilization (bilateral oophorectomy or hysterectomy).
Exclusion Criteria:
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Prior anaphylactic reaction to 18F-Fluciclovine
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Evidence of leptomeningeal disease
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Prior whole-brain radiation therapy
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Contraindication to MRI (e.g., due to safety reasons, such as presence of a pacemaker)
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Pregnant at the expected time of 18F-fluciclovine administration
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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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Miami Cancer Institute at Baptist Health South Florida | Miami | Florida | United States | 33176 |
Sponsors and Collaborators
- Baptist Health South Florida
- Blue Earth Diagnostics
Investigators
- Principal Investigator: Rupesh R Kotecha, M.D., Miami Cancer Institute/Baptist Health South Florida
Study Documents (Full-Text)
None provided.More Information
Publications
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- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 2021-KOT-003