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11C-Choline

Phase 1

Prostatic Neoplasms | Unknown | Oncology |Avalon GloboCare Corp.|Last Updated: Feb 1, 2021

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment21

FDA Designations

No designations recorded

Clinical trial landscape

11C-Choline · 1 trial · 1 indication

Phase 1 1
NCT02004418A Study for Patients With Prostate Cancer to See Whether Delivering an Extra Dose of Radiation to Parts of the Body With More Cancer is Better Than Standard Treatment in Which the Same Dose of Radiation is Given Throughout the Prostate GlandProstatic Neoplasms
COMPLETED21 Analytics
PHASE1COMPLETED
A Study for Patients With Prostate Cancer to See Whether Delivering an Extra Dose of Radiation to Parts of the Body With More Cancer is Better Than Standard Treatment in Which the Same Dose of Radiation is Given Throughout the Prostate Gland
Prostatic NeoplasmsUnlock trial analytics

Study Endpoints

Primary Endpoints

Determine the toxicity profile of 11C-Choline administration in PET scans, therapeutic response and biochemical recurrence in patients treated with EBRT.
After 3 months
Determine the toxicity profile of 11C-Choline administration in PET scans, therapeutic response and biochemical recurrence in patients treated with EBRT
After 3 years

Secondary Endpoints

Intraprostatic lesion delineation capabilities of 11C-Choline in selected prostate cancer subjects for facilitation of Enhanced EBRT
3 months
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
C-Choline PET ScansEXPERIMENTALRadioactive doses of 11C-Choline: 400 MBq ± 10% per injection, pre-radiation treatment and following treatment at 3 and 6 months

Interventions

NameTypeDescription
11C-CholineRADIATION -
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Eligibility Criteria

Age Range18 Years to N/A
SexMALE
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: 1. Age ≥ 18 years 2. Biopsy proven prostate cancer with an intermediate risk feature defined as 1. Gleason score 7, PSA \<20, T1-T2C or 2. Gleason score 6, PSA 10-20, T1-T2C or 3. Gleason Score 6 or 7, PSA \<20, T2C 3. Localized disease based on staging investigations ...

Countries:Canada
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Frequently asked questions about 11C-Choline

What is 11C-Choline used for in prostatic neoplasms?

11C-Choline is an investigational radiopharmaceutical being studied for use in prostatic neoplasms, or prostate cancer. It is being evaluated in a clinical trial to determine whether delivering an extra dose of radiation to areas with more cancer is better than standard treatment that gives the same radiation dose throughout the prostate gland.

What does 11C-Choline target?

11C-Choline is a radiolabeled form of choline, a natural compound that is taken up by cells. In prostate cancer, choline is incorporated into cell membranes, and its uptake is often increased in malignant tissue. This allows 11C-Choline to be used as a tracer to identify areas of more active cancer for targeted radiation.

Who is developing 11C-Choline?

11C-Choline is being developed by Avalon GloboCare Corp., a biopharmaceutical company. The company's stock is traded under the ticker symbol ALBT. The drug is currently in early-stage clinical development for prostate cancer.

What phase is 11C-Choline in?

11C-Choline is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The Phase 1 trial has been completed, and the drug is still in the early stages of clinical testing.

What clinical trials is 11C-Choline in?

11C-Choline has been studied in one completed Phase 1 clinical trial, identified by the identifier NCT02004418. The trial enrolled 21 male patients with prostate cancer in Canada. It was an uncontrolled, non-randomized study that was not double-blinded, and it used biomarker selection.