NCT06182865

Brief Summary

This is a single-center, prospective, open-labeled, single-arm, interventional study to evaluate liver reserve and tumor response using Ga-68 Dolacga positron emission tomography and the safety of the investigational product in patients with hepatocellular carcinoma before and after proton therapy.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2023

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 13, 2023

Completed
7 days until next milestone

Study Start

First participant enrolled

December 20, 2023

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 27, 2023

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2024

Completed
Last Updated

December 27, 2023

Status Verified

December 1, 2023

Enrollment Period

1 year

First QC Date

December 13, 2023

Last Update Submit

December 13, 2023

Conditions

Hepatic Carcinoma

Outcome Measures

Primary Outcomes (2)

  • Measurement of liver reserve obtained from the Ga-68 Dolacga PET performed in HCC patients before proton therapy.

    The liver reserve parameters obtained from Ga-68 Dolacga PET is expressed in "percentage of injection dose (%ID) and standard uptake value, (SUV)."

    Visit 2 (Day 1)

  • Measurement of liver reserve obtained from the Ga-68 Dolacga PET performed in HCC patients after proton therapy.

    The liver reserve parameters obtained from Ga-68 Dolacga PET is expressed in "percentage of injection dose (%ID) and standard uptake value, (SUV)."

    Visit 4 (Day 84±3)

Secondary Outcomes (8)

  • Number of subjects with clinically significant changes in systolic blood pressure and diastolic blood pressure

    from pre-dose to visit 2 (Day 1), visit 3 (Day 7±2), visit 4 (84±3), and visit 5 (Day 91±2)

  • Number of subjects with body temperature abnormalities

    from pre-dose to visit 2 (Day 1), visit 3 (Day 7±2), visit 4 (84±3), and visit 5 (Day 91±2)

  • Number of subjects with clinically significant changes in Heart Rate

    from pre-dose to visit 2 (Day 1), visit 3 (Day 7±2), visit 4 (84±3), and visit 5 (Day 91±2)

  • Number of subjects reporting clinically significant changes in serum biochemical tests

    from pre-dose to visit 2 (Day 1), visit 3 (Day 7±2), visit 4 (84±3), and visit 5 (Day 91±2)

  • Number of subjects reporting clinically significant changes in hematological tests

    from pre-dose to visit 2 (Day 1), visit 3 (Day 7±2), visit 4 (84±3), and visit 5 (Day 91±2)

  • +3 more secondary outcomes

Study Arms (1)

Ga-68 Dolacga Injection

EXPERIMENTAL

Ga-68 Dolacga Injection, 2.0±1.0 mCi, single dose, iv bolus

Drug: Ga-68 Dolacga Injection

Interventions

Ga-68 Dolacga InjectionDRUG

Ga-68 Dolacga will be administered via iv bolus injection followed by a whole-body PET/CT scan for liver reserve evaluation.

Ga-68 Dolacga Injection

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosed with hepatocellular carcinoma and scheduled to have the PBT.
  • \~80 years old
  • Performance status: ECOG 0-1
  • Child-Pugh class A

You may not qualify if:

  • Massive or uncontrolled ascites
  • Concurrent with other malignancy
  • Under pregnancy or breastfeeding
  • With distant metastasis
  • Allergic to investigational drug(s) or similar drug(s)/ formulation(s);
  • Known hypersensitivity to PRIMOVIST
  • Acute or chronic severe renal insufficiency (glomerular filtration rate \<30 mL/min/1.73m\^2)
  • Can't follow our follow-up schedule because of any reason

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Linkon Chang Gung Memorial Hospital

Taoyuan, 333423, Taiwan

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsLiver NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesLiver Diseases

Study Officials

  • Bing-Shen Huang, MD

    Linkon Chang Gung Memorial Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Mei-Hui Wang, PhD

CONTACT

+886-3-4711400mhwang@nari.org.tw

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 13, 2023

First Posted

December 27, 2023

Study Start

December 20, 2023

Primary Completion

December 30, 2024

Study Completion

December 30, 2024

Last Updated

December 27, 2023

Record last verified: 2023-12

Data Sharing

IPD Sharing
Will not share

Locations

TW(1)