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Radioisotope Therapy

DOTA-5G Pair for Pancreatic Cancer

Phase < 1

Recruiting

Led By Julie L Sutcliffe

Research Sponsored by University of California, Davis

Eligibility Criteria Checklist

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

Must have

The presence of at least one measurable disease by [68Ga]Ga DOTA-5G PET/CT (SUVmax>2-fold above normal lung or liver)

Eastern Cooperative Oncology Group Performance Status ≤ 2

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 7-14 days from time of injection

Awards & highlights

Study Summary

This trial will test a new theranostic pair to treat pancreatic cancer. The goal is to find out if it is safe and effective.

Who is the study for?

This trial is for adults over 18 with advanced or metastatic pancreatic cancer who have finished chemotherapy at least two weeks prior and resolved any significant side effects. They must be able to lie still for scans, not have other active cancers needing treatment, no major surgery recently or coming up soon, and no severe infections or heart failure.Check my eligibility

What is being tested?

The study tests a new theranostic pair [68Ga]Ga DOTA-5G (for imaging) and [177Lu]Lu DOTA-ABM-5G (for therapy) in patients with pancreatic cancer. It aims to assess the safety and effectiveness of these agents in detecting and treating the disease.See study design

What are the potential side effects?

As this is a first-in-human study, specific side effects are unknown but may include reactions related to radiation exposure from the imaging agent and therapeutic compound.

Eligibility Criteria

Inclusion Criteria

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

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My scans show at least one cancer spot that's clearly visible.

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I can take care of myself but might not be able to do heavy physical work.

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I finished my last chemotherapy over 2 weeks ago and any side effects have mostly gone.

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My pancreatic cancer is advanced and cannot be removed by surgery.

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I am 18 years old or older.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 7-14 days from time of injection

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~7-14 days from time of injection

This trial's timeline: 3 weeks for screening, Varies for treatment, and 7-14 days from time of injection for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

[177Lu]Lu DOTA-ABM-5G dose escalation therapy

[68Ga]Ga DOTA-5G PET/CT imaging

Secondary outcome measures

Assessment of organ dosimetry of [177Lu]Lu DOTA-ABM-5G

Trial Design

2Treatment groups

Experimental Treatment

Group I: [177Lu]Lu DOTA-ABM-5G dose escalation therapy studyExperimental Treatment1 Intervention

Patients will be undergo [68Ga]Ga DOTA-5G PET/CT scans to confirm eligibility for the [177Lu]Lu DOTA-ABM-5G therapy. Patients with sufficient lesion uptake of [68Ga]Ga DOTA-5G PET/CT will be offered therapy. Escalating doses of 25-200 mCi of [177Lu]Lu DOTA-ABM-5G will be administered in a traditional 3+3 dose escalation design. After escalation, 10 additional patients will be enrolled into a dose expansion cohort.

Group II: Recommended Phase 2 dose [177Lu]Lu DOTA-ABM-5G therapy studyExperimental Treatment1 Intervention

Patients will be undergo [68Ga]Ga DOTA-5G PET/CT scans to confirm eligibility for the [177Lu]Lu DOTA-ABM-5G therapy.10 patients will be enrolled in the dose expansion cohort and recieve the highest dose achieved in the [177Lu]Lu DOTA-ABM-5G dose escalation therapy study

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of California, DavisLead Sponsor

911 Previous Clinical Trials

4,709,553 Total Patients Enrolled

Julie L SutcliffePrincipal InvestigatorUniversity of California, Davis

Media Library

[177Lu]Lu DOTA-ABM-5G (Radioisotope Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT04665947 — Phase < 1

Pancreatic Cancer Research Study Groups: [177Lu]Lu DOTA-ABM-5G dose escalation therapy study, Recommended Phase 2 dose [177Lu]Lu DOTA-ABM-5G therapy study

Pancreatic Cancer Clinical Trial 2023: [177Lu]Lu DOTA-ABM-5G Highlights & Side Effects. Trial Name: NCT04665947 — Phase < 1

[177Lu]Lu DOTA-ABM-5G (Radioisotope Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04665947 — Phase < 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Could you provide a comprehensive overview of past experiments utilizing [68Ga]Ga DOTA-5G and [177Lu]Lu DOTA-ABM-5G?

"Presently, 30 clinical studies are ongoing for [68Ga]Ga DOTA-5G and [177Lu]Lu DOTA-ABM-5G. Three of these trials are in their third phase of development. The majority of the research is conducted at Newcastle and Gateshead; however, there exist an additional 238 locations across the globe exploring this revolutionary treatment option."

Answered by AI

What is the upper cap of participants for this trial?

"Affirmative. According to information hosted on clinicaltrials.gov, the trial is still recruiting participants after it was posted on December 18th 2020 and last modified on April 21st 2022. Recruitment will take place at a single site with 30 patients in total needed for participation."

Answered by AI

Are there any vacancies available for participants in this investigation?

"Affirmative. Clinicaltrials.gov officially lists this medical trial as actively recruiting patients since December 18th 2020, with the last update on April 21st 2022. The research team requires at least 30 people to be recruited from a single site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

First-in-human Study of the Theranostic Pair [68Ga]Ga DOTA-5G and [177Lu]Lu DOTA-ABM-5G in Pancreatic Cancer

Julie L. Sutcliffe, Ph.D 2020. "First-in-human Study of the Theranostic Pair [68Ga]Ga DOTA-5G and [177Lu]Lu DOTA-ABM-5G in Pancreatic Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04665947.