NCT06103838Toboroz2. fázis
18F-Fluciclovine PET/CT in Multiple Myeloma
A Phase II Trial Evaluating 18F-Fluciclovine PET/CT in Multiple Myeloma
Forrás: ClinicalTrials.gov · Utoljára frissítve: 2026. okt. 29.
Rövid összefoglaló (regiszter, angolul)
Background: Multiple myeloma (MM) is an incurable cancer of certain blood cells. MM often returns after treatment, and most people survive only 5 to 8 years after diagnosis. To improve survival, researchers need to find ways to identify returning disease earlier. Objective: To find out if the radiotracer 18F-fluciclovine (a substance injected into the blood during imaging scans) is better at detecting MM than the one (18F-FDG) currently used for this purpose. Eligibility: Adults aged 18 years or older with MM. The MM may be newly diagnosed (NDMM); or it may have returned or failed to respond after at least 1 prior line of treatment (RRMM). Design: Participants will be screened. They will have blood tests. They will have a positron emission tomography (PET) or computed tomography (CT) scan using 18F-FDG. The radiotracer will be injected into a vein. Then participants will lie on a table while the PET/CT scan takes images of their body. All participants will have 3 study visits. During each visit they will have: Two PET/CT scans. One with 18F-FDG, one with 18F-fluciclovine. An optional magnetic resonance imaging scan. A bone marrow biopsy. An area on the hip will be numbed; a needle will be inserted to draw out a sample of the soft tissue from inside the bone. These tests may be spread over 30 days for each visit. NDMM participants will have their second study visit 2 to 4 weeks after they complete their usual treatment for the disease. RRMM participants will have their second visit 6 months after their first. All participants will have a third study visit after 5 years or when their disease progresses.
- Állapot (regiszter)
- Toboroz
- Fázis (regiszter)
- 2. fázis
- Vizsgálattípus
- Beavatkozással járó
- Résztvevők száma
- 60 (tervezett)
- Első benyújtás
- 2023. okt. 26.
- Kezdés
- 2024. márc. 25.
- Elsődleges befejezés
- 2027. dec. 6.
- Fő szponzor
- National Cancer Institute (NCI)
- Betegségek
- Mielóma multiplex
- NCT-szám
- NCT06103838
Mit vállalsz
- Vizsgálat típusa: Beavatkozással járó · 2. fázis
- Tervezett résztvevők: 60
- 2024. márc. 25. és az elsődleges befejezés (2027. dec. 6.) között
- 1 helyszín, 1 országban
- Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket
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Korábbi kezelés
- Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with 18F-fluciclovine, breastfeeding should be discontinued if the mother is treated with 18F-fluciclovine until 3 days after 18F-fluciclovine.
Más betegség
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to 18F-FDG
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to 18F-fluciclovine or other similar agents.
- Uncontrolled intercurrent illness including, psychiatric illness/social situations that would limit compliance with study requirements.
Egyéb
- Subjects with severe claustrophobia unresponsive to oral anxiolytics or unwilling to take them.
A regiszterben nem jelölt feltételek
- INCLUSION CRITERIA:
- Participants must have a documented diagnosis of MM defined by the IMWG Criteria. Participants at diagnosis must have had a serum M-protein >= 3 g/dL and/or bone marrow plasma cells >= 10% and at least one of the following:
- Anemia: Hemoglobin <=10 g/dL, or
- Renal Failure: serum creatinine >= 2.0 mg/dL, or
- Hypercalcemia: Ca >= 10.5 mg/dL, or
- Lytic bone lesions on X-ray, CT, or PET/CT, or
- >= 2 focal lesions on spinal MRI, or
- >= 60% bone marrow plasma cells, or
- Involved/un-involved serum free light chain ration >= 100
- Participants must have measurable disease defined by any one of the following:
- Monoclonal bone marrow plasma cells > 5%
- Serum monoclonal protein >= 0.2 g/dl
- Urine monoclonal protein > 200 mg/24 hr
- Serum immunoglobulin free light chain > 10 mg/dL AND abnormal kappa/lambda ratio
- A measurable lesion on PET/CT or MRI
- Participants fit criteria for one of the following categories:
- Newly diagnosed multiple myeloma (NDMM)
- Relapsed and/or refractory multiple myeloma (RRMM) with at least 1 prior line of therapy
- Age >=18 years.
- ECOG performance status <= 2
- Negative serum or urine pregnancy test at screening for WOCBP.
- Women of child-bearing potential and men must agree to use effective contraception (hormonal or barrier method of birth control; abstinence) 24 hours prior to and for the 24 hours after each 18F-fluciclovine administration.
- Ability of subject to understand and the willingness to sign a written informed consent document.
Életkor a regiszterben: 18 év – 120 év · Nem: nők és férfiak · Egészséges önkénteseket nem fogad
Helyszínek (1)
Helyszínek a regiszter sorrendjében. Ha a profilodba mented a városodat, távolság szerint rendeződnek.
| Helyszín | Város | Ország | Helyszín állapota |
|---|---|---|---|
| National Institutes of Health Clinical Center | Bethesda | Egyesült Államok | Toboroz |
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