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motexafin gadolinium for Prostate Cancer (A6701QIBA Trial)
N/A
Waitlist Available
Led By Mark A. Rosen
Research Sponsored by American College of Radiology Imaging Network
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 to 14 days
Awards & highlights
A6701QIBA Trial Summary
This trial is looking at whether diagnostic procedures like DCE-MRI and DWI can help to image prostate cancer or any cancer that is left after a biopsy.
Eligible Conditions
- Prostate Cancer
A6701QIBA Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 to 14 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 to 14 days
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Repeatability assessment of DCE-MRI metrics Ktrans and blood-normalized initial area under the gadolinium curve (IAUGC90bn) and the DWI metric D(t)
Secondary outcome measures
Comparison between T1-dependent or T1-independent methods for gadolinium quantification produce differing values for the RC for Ktrans
Neoplasms
Side effects data
From 2010 Phase 2 trial • 64 Patients • NCT0038779011%
Lymphocyte count decreased
10%
Alanine aminotransferase increased
8%
Hypertension
5%
Hypophosphatemia
5%
Peripheral motor neuropathy
5%
Weight gain
3%
White blood cell decreased
3%
Hyperglycemia
3%
Hypermagnesemia
3%
Hypokalemia
3%
Otitis media
3%
Pain in extremity
3%
Headache
3%
Hypoalbuminemia
3%
Ataxia
3%
Fever
3%
Hydrocephalus
3%
Infections and infestations - Other, specify
3%
Rash maculo-papular
3%
Anorexia
3%
Palmar-plantar erythrodysesthesia syndrome
3%
Peripheral sensory neuropathy
2%
Dysphasia
2%
Encephalopathy
2%
Pain
2%
Lung infection
2%
Hypoglycemia
2%
Cushingoid
2%
Constipation
2%
Neutrophil count decreased
2%
Glossopharyngeal nerve disorder
2%
Hyponatremia
2%
Ileus
2%
Dysphagia
2%
External ear inflammation
2%
Facial nerve disorder
2%
Irritability
2%
Mucositis oral
2%
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify
2%
Diarrhea
2%
Hyperuricemia
2%
Hypocalcemia
2%
Dyspnea
2%
Bladder infection
2%
Catheter related infection
2%
Fatigue
2%
Extraocular muscle paresis
2%
Allergic reaction
2%
Hypotension
2%
Hypoxia
2%
Abducens nerve disorder
2%
Anaphylaxis
2%
Skin infection
2%
Weight loss
2%
Alkaline phosphatase increased
2%
Allergic rhinitis
2%
Alopecia
2%
Apnea
2%
Aspartate aminotransferase increased
2%
Pruritus
2%
Upper respiratory infection
2%
Urine discoloration
2%
Vomiting
100%
80%
60%
40%
20%
0%
Study treatment Arm
Radiation and Motexafin Gadolinium
A6701QIBA Trial Design
1Treatment groups
Experimental Treatment
Group I: Repeatability AssessmentExperimental Treatment1 Intervention
Gadolinium motexafin gadolinium All participants will undergo two consecutive DCE-MRI and DWI scans per same imaging parameters and subsequent comparison for repeatability.
Find a Location
Who is running the clinical trial?
American College of Radiology Imaging NetworkLead Sponsor
39 Previous Clinical Trials
466,845 Total Patients Enrolled
2 Trials studying Prostate Cancer
57 Patients Enrolled for Prostate Cancer
National Cancer Institute (NCI)NIH
13,665 Previous Clinical Trials
40,925,824 Total Patients Enrolled
560 Trials studying Prostate Cancer
507,065 Patients Enrolled for Prostate Cancer
Mark A. RosenPrincipal InvestigatorAbramson Cancer Center at Penn Medicine
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