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[68Ga]CBP8 Imaging for Radiation-Induced Tissue Injury

Phase 2

Recruiting

Led By Michael Lanuti, MD

Research Sponsored by Massachusetts General Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Subjects required to undergo pre-surgical CT of abdomen within 1 month after completion of standard neoadjuvant CRT as part of routine clinical work-up

Scheduled surgical pancreas resection within 1 month after post-CRT study visit

Must not have

Unable to lie comfortably on a bed inside the MR-PET for pancreatic cancer subjects

Research-related radiation exposure exceeds current Radiology Department guidelines (i.e. 50 mSv in the prior 12 months) for pancreatic cancer subjects

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3-6 months

Awards & highlights

No Placebo-Only Group

Summary

This trial will test if a new imaging agent can detect collagen damage caused by radiation therapy.

Who is the study for?

This trial is for adults with a life expectancy over 3 months who have certain types of cancer (like lung or pancreatic) and are not using tobacco. They must be able to consent, fit within MRI weight limits, and not have metal implants or severe claustrophobia. Pregnant women can't participate.

What is being tested?

[68Ga]CBP8 is being tested to see if it's effective in detecting collagen in tissues damaged by radiation. Participants will undergo PET-MRI scans with this probe to assess its efficacy.

What are the potential side effects?

Potential side effects may include reactions related to the PET-MRI contrast agent used during scanning, such as allergic reactions or discomfort from lying still during the scan.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I will have a CT scan of my abdomen within 1 month after finishing my initial cancer treatment.

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I am scheduled for pancreas surgery within a month after my next study visit.

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My diagnosis of pancreatic cancer is confirmed by lab tests on tissue or fluid samples.

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I am older than 18 years.

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I am 18 years or older with pancreatic cancer.

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My lung cancer is at an advanced stage but cannot be removed by surgery.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I cannot lie comfortably on my back for scans due to my pancreatic cancer.

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I have been exposed to more than the recommended amount of radiation for pancreatic cancer research.

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I am claustrophobic and have pancreatic cancer.

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I haven't had pneumonia or a serious lung infection in the last 6 weeks.

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I have had radiation therapy to my upper abdomen for pancreatic cancer.

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I weigh less than or equal to 300 lbs.

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I am claustrophobic.

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My BMI is 33 or less.

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I cannot lie comfortably in an MR-PET scanner.

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I have been exposed to more than 50 mSv of radiation for my lung cancer in the last year.

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I do not have metal implants or metallic tattoos that could interfere with medical scans.

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I've had an allergic reaction to MRI dye before.

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I do not have metal implants or metallic tattoos that could interfere with medical scans.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3-6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3-6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3-6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Ability of [68Ga]CBP8 to detect collagen deposition in areas of radiation injury.

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Lung Cancer or Pancreatic Cancer Subjects Undergoing Radiation TherapyExperimental Treatment1 Intervention

Lung cancer or pancreatic cancer patients will receive \[68Ga\]CBP8 and undergo PET imaging 1) prior to radiation therapy and 2) 3-6 months after radiation therapy

0 / 19Eligibility criteria met