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Radiopharmaceutical
[68Ga]Pentixafor for Neuroendocrine Cancer
Phase < 1
Waitlist Available
Led By Yusuf Menda, MD
Research Sponsored by Yusuf Menda
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age ≥ 18 years
Histological diagnosis of neuroendocrine tumor (NET)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up within 1 month of the second [68ga]pentixafor scan
Awards & highlights
Study Summary
This trial will study how a Gallium-68 Pentixafor is distributed in neuroendocrine tumor patients and if that distribution is consistent through repeated scans.
Who is the study for?
Adults over 18 with a confirmed neuroendocrine tumor, registered in the Iowa Neuroendocrine Tumor Registry, who've had specific scans within the last 3 months without significant treatment changes. Excludes pregnant women, those planning NET therapy between scans (except for Somatostatin analog), and anyone with illnesses or conditions that could interfere with study participation.Check my eligibility
What is being tested?
[68Ga]Pentixafor's distribution in patients' bodies is being tested to see if it's consistent across multiple scans. This research doesn't apply clinically; images can't be used for medical decisions or shared with oncologists.See study design
What are the potential side effects?
Since this trial focuses on imaging rather than drug effects, side effects are not a primary concern. However, typical risks associated with PET/CT scans may include discomfort from lying still and exposure to low levels of radiation.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
Select...
I have been diagnosed with a neuroendocrine tumor.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ within 1 month of [68ga]pentixafor scan
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~within 1 month of [68ga]pentixafor scan
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Determine biodistribution (pharmacokinetic parameters) of [68Ga]Pentixafor in patients with neuroendocrine tumors (NETs)
Determine the repeatability of [68Ga]Pentixafor uptake in known neuroendocrine tumor lesions
Secondary outcome measures
Compare standardized uptake values of [68Ga]Pentixafor and [68Ga]DOTATATE in known neuroendocrine tumor lesions
Correlate the uptake of [68Ga]Pentixafor and [68Ga]DOTATATE (NetSpot) in known neuroendocrine tumor lesions with expression of receptors (CXCR4 and SSTR2) in biopsy tissue samples.
Trial Design
1Treatment groups
Experimental Treatment
Group I: [68Ga]Pentixafor PET scanExperimental Treatment1 Intervention
4 mCi (range 3-5 mCi) of [68Ga]Pentixafor is administered intravenously over 1 minute using an infusion pump. PET imaging is performed from time of infusion for about 90 minutes. Approximately 12 blood samples (~ 1 tsp) will be taken for pharmacokinetic analysis.
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)NIH
13,677 Previous Clinical Trials
40,927,016 Total Patients Enrolled
78 Trials studying Neuroendocrine Tumors
43,543 Patients Enrolled for Neuroendocrine Tumors
Holden Comprehensive Cancer CenterOTHER
26 Previous Clinical Trials
747 Total Patients Enrolled
5 Trials studying Neuroendocrine Tumors
87 Patients Enrolled for Neuroendocrine Tumors
National Institutes of Health (NIH)NIH
2,705 Previous Clinical Trials
7,507,348 Total Patients Enrolled
7 Trials studying Neuroendocrine Tumors
122 Patients Enrolled for Neuroendocrine Tumors
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a tumor larger than 1.5 cm, confirmed by CT or MRI in the last 3 months.I am not planning to receive any NET therapy except for Somatostatin analog between two specific scans.I am 18 years old or older.I have been diagnosed with a neuroendocrine tumor.I do not have any severe illnesses or social situations that would stop me from following the study's requirements.I have a physical condition that may prevent me from following the study's requirements.I've had specific scans within the last 3 months and no treatment except for a hormone therapy.
Research Study Groups:
This trial has the following groups:- Group 1: [68Ga]Pentixafor PET scan
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any active enrollment opportunities for this clinical investigation?
"Affirmative. According to clinicaltrials.gov, this study is accepting enrollees as of now. Originally posted on November 3rd 2017, the trial was recently revised on September 15th 2022 and requires 30 participants from a single clinic site."
Answered by AI
How many participants have been enrolled in this experiment?
"Affirmative. According to clinicaltrials.gov, this study is currently accepting participants. Initially posted on November 3rd 2017 and recently updated on September 15th 2022, the trial needs 30 individuals from a single location."
Answered by AI
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